Pulmonary Disease, Chronic ObstructivePhase 1NCT03235726

Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug

A Phase 1 study testing CCI15106 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: CCI15106
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 1 siteUnited Kingdom
Study dates: 13 Jul 2017to 19 Jun 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Some important Inclusion Criteria:

For healthy subjects and bystanders:

18 to 65 years of age.
Healthy as determined by a doctor.
Men who agree to use contraception during the treatment period and for at least 7 months after the last dose of study medicine and agree not to donate sperm during this period.
Women who are not pregnant or breastfeeding, and not of childbearing potential.

For subjects with COPD:

40 to 75 years of age.
Diagnosed with moderate COPD by a doctor.
Have breathing test results that are consistent with moderate COPD as defined in the study protocol.
A smoker or an ex-smoker.
Men who agree to use contraception during the treatment period and for at least 7 months after the last dose of study medicine and agree not to donate sperm during this period.
Women who are not pregnant or breastfeeding, and not of childbearing potential.

Some Important Exclusion Criteria:

For healthy subjects and bystanders:

History of liver disease.
Use of over-the-counter or prescription drugs (including vitamins) 7 days before the study until completion of the follow-up visit.
Participation in the study would result in loss of more than 500 milliliter (mL) of blood within 3 months.
Participation in another clinical trial with an investigational product within about 3 months before this study.
Positive drug/alcohol screen.
Regular use of known drugs of abuse.
Regular alcohol consumption within 3 months before the study.
Breath test indicative of smoking at study start.
Documented lactose allergy/intolerance.
Men whose partner is pregnant or breastfeeding cannot participate.
Certain blood test results may not allow subjects to participate, as described in the study protocol.

For subjects with COPD:

History of liver disease.
Poorly controlled COPD disease as, for example, more than 2 exacerbations of COPD per year.
Some respiratory conditions, like for example active tuberculosis, lung cancer or any other respiratory condition. Subjects with other respiratory conditions (for example, clinically significant: asthma, pulmonary fibrosis, bronchiectasis) are excluded if these conditions are the primary cause of their respiratory symptoms.
Unstable or uncontrolled cardiac disease.
Problems with kidney function as defined in the study protocol.
Past or current medical conditions or diseases that are not well controlled.
Subjects are not allowed to take oral corticosteroids from 4 weeks prior to screening and for the duration of the study.
Subjects taking medications for any chronic conditions have to be on stable doses for 4 weeks before screening and until after study treatment is finished.
Use of short-acting inhaled bronchodilators is allowed, but subjects must be able to stop their medications several times during the study.
Use of long-acting bronchodilators is allowed, but subjects must be able to change the schedule of their medications twice during the study.
Participation in the study would result in loss of more than 500 mL within 3 months.
Participation in another clinical trial with an investigational product within about 3 months before this study.
Positive drug/alcohol screen.
Regular use of known drugs of abuse.
Regular alcohol consumption within 3 months before the study.
Unable to refrain from smoking for certain periods during the study (maximum about 6 hours).
Documented lactose allergy/intolerance.
Men whose partner is pregnant or breastfeeding cannot participate.
Certain blood test results may not allow subjects to participate, as described in the study protocol.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Park Royal, London, NE10 7EW

Other trials in United Kingdom

About this study

Official title: A Double-blind (Sponsor Unblind), Randomized, Placebo-controlled, Single and Repeat Escalating Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of CCI15106 Inhalation Powder in Healthy Participants and Participants With Moderate Chronic Obstructive Pulmonary Disease (COPD) Including Evaluation of Environmental and Healthy By-stander Exposure Levels During Dosing

This single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of the CCI15106 inhalation powder. The study will also look at the level of CCI15106 that will be released into the air and may be found in the blood of the people standing around the person inhaling it (bystanders). This is a two-part study in which Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part 2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and approximately 22 subjects with COPD will be randomized in this study for dosing. The total study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: CCI15106, Placebo
Keywords: bystander, inhalation powder, monodose device, COPD, pharmacokinetics, safety, Healthy, CCI15106, tolerability
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CCI15106Drug
One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.
PlaceboDrug
One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Study groups in NCT03235726
Study group	Role	What they receive
Cohort A, Part 1: Active	Experimental	60 milligrams (mg) single dose of CCI15106 will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered twice daily (BID) on Days 6-19 to healthy subjects. Receives: Drug: CCI15106
Cohort A, Part 1: Placebo	Placebo comparator	60 mg single dose of placebo will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered BID on Days 6-19 to healthy subjects. Receives: Drug: Placebo
Cohort B, Part 1: Active	Experimental	60 mg of CCI15106 BID will be administered by inhalation route for 14 days to healthy subjects. Receives: Drug: CCI15106
Cohort B, Part 1: Placebo	Placebo comparator	60 mg of placebo BID will be administered by inhalation route for 14 days to healthy subjects. Receives: Drug: Placebo
Cohort C, Part 1: bystanders	No intervention	Healthy subjects will be enrolled to follow bystander exposure and will be studied concomitantly with Cohort B.
Cohort A, Part 2: Active	Experimental	60 mg single dose of CCI15106 will be administered by inhalation route to subjects with COPD. Receives: Drug: CCI15106
Cohort A, Part 2: Placebo	Placebo comparator	60 mg single dose of placebo will be administered by inhalation route to subjects with COPD. Receives: Drug: Placebo
Cohort B, Part 2: Active	Experimental	60 mg BID dose of CCI15106 will be administered by inhalation route for 14 days to subjects with COPD. Receives: Drug: CCI15106
Cohort B, Part 2: Placebo	Placebo comparator	60 mg BID dose of placebo will be administered by inhalation route for 14 days to subjects with COPD. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Safety population comprised of all participants who received at least one dose of study treatment during the study.
Measured: Up to 51 days
Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
Measured: Up to 46 days
Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
Measured: Up to 46 days
Part 2 Cohort A: Number of Participants With NSAEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
Measured: Up to 33 days
Part 2 Cohort B: Number of Participants With NSAEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
Measured: Up to 46 days
Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106
PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of red blood cell [RBC] in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 grams [g]/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.
Measured: Up to 51 days
Part 1: Number of Participants With Hematology Values of PCI in Bystanders
PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of RBC in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 g/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.
Measured: Up to 46 days
Part 2: Number of Participants With Hematology Values of PCI
PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of RBC in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 g/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.
Measured: Up to 46 days
Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 millimole per liter [mmol/L]), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.
Measured: Up to 51 days
Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 mmol/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.
Measured: Up to 46 days
Part 2: Number of Participants With Clinical Chemistry Values of PCI
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 mmol/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.
Measured: Up to 46 days
Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Measured: Baseline (Day -1) and Day 2
Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD
Urine sample was collected from participants at indicated time point for analysis of pH.
Measured: Day 5
Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID
Urine samples were collected from participants at indicated time points for analysis of pH.
Measured: Days 12 and 22
Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Measured: Baseline (Day -1), Days 7 and 15
Part 1: pH Value by Visit- Placebo
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Measured: Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22
Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Measured: Baseline (Day -1), Days 7 and 15
Part 2 Cohort A: pH Value by Visit- CCI15106
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Measured: Baseline (Day -1) and Day 2
Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Measured: Baseline (Day -1), Days 7 and 15
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Measured: Baseline (Day -1) and Day 2
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity.
Measured: Day 5
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity.
Measured: Days 12 and 22
Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Measured: Baseline (Day -1), Days 7 and 15
Part 1: Specific Gravity Value by Visit- Placebo
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Measured: Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22
Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Measured: Baseline (Day -1), Days 7 and 15
Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Measured: Baseline (Day -1) and Day 2
Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Measured: Baseline (Day -1), Days 7 and 15
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 milliseconds (msec), absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported.
Measured: Up to 51 days
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 msec, absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. Data for worst case post-Baseline has been reported.
Measured: Up to 46 days
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 msec, absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. Data for worst case post-Baseline has been reported.
Measured: Up to 46 days
Part 1: Number of Participants With Abnormal Telemetry Findings
Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Measured: Days 1, 3, 6, 7, 12 and 18: 0.5 hour (pre-dose) to 4 hours post-dose
Part 2: Number of Participants With Abnormal Telemetry Findings
Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Measured: Days 1, 7, 12 and 13: 0.5 hour (pre-dose) to 4 hours post-dose
Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.
Measured: Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose
Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.
Measured: Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose
Part 2: Percent Predicted FEV1 at Indicated Time Points
FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.
Measured: Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose
Part 2: Percent Predicted FVC at Indicated Time Points
FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.
Measured: Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose
Part 1: Number of Participants With Vital Signs Values of PCI
PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) <85 and >160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) <45 and >100 mmHg and heart rate <40 and >110 beats per minute (bpm). Data for the participants with high and low values has been reported.
Measured: Up to 51 days
Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders
PCI ranges for the vital signs parameters were as follows: SBP <85 and >160 mmHg, DBP <45 and >100 mmHg and heart rate <40 and >110 bpm. Data for the participants with high and low values has been reported.
Measured: Up to 46 days
Part 2: Number of Participants With Vital Signs Values of PCI
PCI ranges for the vital signs parameters were as follows: SBP <85 and >160 mmHg, DBP <45 and >100 mmHg and heart rate <40 and >110 bpm. Data for the participants with high and low values has been reported.
Measured: Up to 46 days
Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data.
Measured: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data.
Measured: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data.
Measured: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data.
Measured: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data.
Measured: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data.
Measured: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data.
Measured: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.
Measured: Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose
Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.
Measured: Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose
Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data.
Measured: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data.
Measured: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data.
Measured: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.
Measured: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C
Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result.
Measured: Days 1, 7 and 14: pre-dose, 15 minutes post-dose
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room.
Measured: Days 1, 7 and 14: 15 minutes post-dose
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing.
Measured: Days 1, 7 and 14: 20 and 60 minutes post-dose

Secondary outcomes (3)

Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg
Bronchoalveolar lavage samples for ELF concentration analysis of CCI15106 were collected up to Day 13. Participants who received at least one dose of study treatment and who underwent bronchoalveolar lavage (BAL) sampling and had post-dose lung ELF CCI15106 and urea concentration result were included in BAL PK Population.
Measured: Up to Day 13
Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg
BAL samples for ELF concentration analysis of CCI15106 were collected up to Day 13.
Measured: Up to Day 13
Part 1: Number of Participants With Medical Device Incidents in CCI15106
A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a participant/user/other person or to a serious deterioration in his/her state of health.
Measured: Up to Day 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 201719 Jun 2018

First posted1 Aug 2017
Study start13 Jul 2017
Primary completion19 Jun 2018
Study completion19 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: In this study, subjects will be randomized to receive either study drug or placebo in a parallel manner.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03235726
Sponsor's protocol ID: 205822
Other IDs: 2017-001070-42, 2017
Status last verified: Jun 2020
First submitted: 11 Jul 2017
Last updated: 8 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Dumont EF, Oliver AJ, Ioannou C, Billiard J, Dennison J, van den Berg F, Yang S, Chandrasekaran V, Young GC, Lahiry A, Starbuck DC, Harrell AW, Georgiou A, Hopchet N, Gillies A, Baker SJ. A Novel Inhaled Dry-Powder Formulation of Ribavirin Allows for Efficient Lung Delivery in Healthy Participants and Those with Chronic Obstructive Pulmonary Disease in a Phase 1 Study. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02267-19. doi: 10.1128/AAC.02267-19. Print 2020 Apr 21.
PubMed 32071044

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind (Sponsor Unblind), Randomized, Placebo-controlled, Single and Repeat Escalating Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of CCI15106 Inhalation Powder in Healthy Participants and Participants With Moderate Chronic Obstructive Pulmonary Disease (COPD) Including Evaluation of Environmental and Healthy By-stander Exposure Levels During Dosing
ClinicalTrials.gov ID: NCT03235726
Acronym / sponsor ID: 205822
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: bystander, inhalation powder, monodose device, COPD, pharmacokinetics, safety, Healthy, CCI15106
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 13 Jul 2017 (actual)
Primary completion: 19 Jun 2018 (actual)
Study completion: 19 Jun 2018 (actual)
First posted: 1 Aug 2017 (actual)
Results: Posted 27 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 9
Model description: In this study, subjects will be randomized to receive either study drug or placebo in a parallel manner.

Arm	Type	Receives
Cohort A, Part 1: Active	Experimental	Drug: CCI1510660 milligrams (mg) single dose of CCI15106 will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered twice daily (BID) on Days 6-19 to healthy subjects.
Cohort A, Part 1: Placebo	Placebo comparator	Drug: Placebo60 mg single dose of placebo will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered BID on Days 6-19 to healthy subjects.
Cohort B, Part 1: Active	Experimental	Drug: CCI1510660 mg of CCI15106 BID will be administered by inhalation route for 14 days to healthy subjects.
Cohort B, Part 1: Placebo	Placebo comparator	Drug: Placebo60 mg of placebo BID will be administered by inhalation route for 14 days to healthy subjects.
Cohort C, Part 1: bystanders	No intervention	–Healthy subjects will be enrolled to follow bystander exposure and will be studied concomitantly with Cohort B.
Cohort A, Part 2: Active	Experimental	Drug: CCI1510660 mg single dose of CCI15106 will be administered by inhalation route to subjects with COPD.
Cohort A, Part 2: Placebo	Placebo comparator	Drug: Placebo60 mg single dose of placebo will be administered by inhalation route to subjects with COPD.
Cohort B, Part 2: Active	Experimental	Drug: CCI1510660 mg BID dose of CCI15106 will be administered by inhalation route for 14 days to subjects with COPD.
Cohort B, Part 2: Placebo	Placebo comparator	Drug: Placebo60 mg BID dose of placebo will be administered by inhalation route for 14 days to subjects with COPD.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CCI15106One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.	Drug	Cohort A, Part 1: Active, Cohort A, Part 2: Active, Cohort B, Part 1: Active, Cohort B, Part 2: Active
PlaceboOne capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.	Drug	Cohort A, Part 1: Placebo, Cohort A, Part 2: Placebo, Cohort B, Part 1: Placebo, Cohort B, Part 2: Placebo

Primary outcome

Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106
Time frame: Up to 51 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Safety population comprised of all participants who received at least one dose of study treatment during the study.
Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106
Time frame: Up to 46 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders
Time frame: Up to 46 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
Part 2 Cohort A: Number of Participants With NSAEs and SAEs
Time frame: Up to 33 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
Part 2 Cohort B: Number of Participants With NSAEs and SAEs
Time frame: Up to 46 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106
Time frame: Up to 51 days
PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of red blood cell [RBC] in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 grams [g]/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.
Part 1: Number of Participants With Hematology Values of PCI in Bystanders
Time frame: Up to 46 days
PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of RBC in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 g/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.
Part 2: Number of Participants With Hematology Values of PCI
Time frame: Up to 46 days
PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of RBC in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 g/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.
Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
Time frame: Up to 51 days
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 millimole per liter [mmol/L]), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.
Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
Time frame: Up to 46 days
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 mmol/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.
Part 2: Number of Participants With Clinical Chemistry Values of PCI
Time frame: Up to 46 days
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 mmol/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.
Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD
Time frame: Baseline (Day -1) and Day 2
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD
Time frame: Day 5
Urine sample was collected from participants at indicated time point for analysis of pH.
Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID
Time frame: Days 12 and 22
Urine samples were collected from participants at indicated time points for analysis of pH.
Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Time frame: Baseline (Day -1), Days 7 and 15
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Part 1: pH Value by Visit- Placebo
Time frame: Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders
Time frame: Baseline (Day -1), Days 7 and 15
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Part 2 Cohort A: pH Value by Visit- CCI15106
Time frame: Baseline (Day -1) and Day 2
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Time frame: Baseline (Day -1), Days 7 and 15
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD
Time frame: Baseline (Day -1) and Day 2
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD
Time frame: Day 5
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity.
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID
Time frame: Days 12 and 22
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity.
Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Time frame: Baseline (Day -1), Days 7 and 15
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Part 1: Specific Gravity Value by Visit- Placebo
Time frame: Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders
Time frame: Baseline (Day -1), Days 7 and 15
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106
Time frame: Baseline (Day -1) and Day 2
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Time frame: Baseline (Day -1), Days 7 and 15
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
Time frame: Up to 51 days
PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 milliseconds (msec), absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported.
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
Time frame: Up to 46 days
PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 msec, absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. Data for worst case post-Baseline has been reported.
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
Time frame: Up to 46 days
PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 msec, absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. Data for worst case post-Baseline has been reported.
Part 1: Number of Participants With Abnormal Telemetry Findings
Time frame: Days 1, 3, 6, 7, 12 and 18: 0.5 hour (pre-dose) to 4 hours post-dose
Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Part 2: Number of Participants With Abnormal Telemetry Findings
Time frame: Days 1, 7, 12 and 13: 0.5 hour (pre-dose) to 4 hours post-dose
Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Time frame: Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose
FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.
Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Time frame: Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose
FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.
Part 2: Percent Predicted FEV1 at Indicated Time Points
Time frame: Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose
FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.
Part 2: Percent Predicted FVC at Indicated Time Points
Time frame: Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose
FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.
Part 1: Number of Participants With Vital Signs Values of PCI
Time frame: Up to 51 days
PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) <85 and >160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) <45 and >100 mmHg and heart rate <40 and >110 beats per minute (bpm). Data for the participants with high and low values has been reported.
Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders
Time frame: Up to 46 days
PCI ranges for the vital signs parameters were as follows: SBP <85 and >160 mmHg, DBP <45 and >100 mmHg and heart rate <40 and >110 bpm. Data for the participants with high and low values has been reported.
Part 2: Number of Participants With Vital Signs Values of PCI
Time frame: Up to 46 days
PCI ranges for the vital signs parameters were as follows: SBP <85 and >160 mmHg, DBP <45 and >100 mmHg and heart rate <40 and >110 bpm. Data for the participants with high and low values has been reported.
Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result.
Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3
Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data.
Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data.
Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.
Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3
Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data.
Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.
Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.
Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3
Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data.
Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.
Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.
Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3
Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data.
Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.
Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.
Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3
Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data.
Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.
Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.
Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3
Time frame: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data.
Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.
Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg
Time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data.
Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
Time frame: Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.
Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
Time frame: Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.
Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg
Time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data.
Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.
Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.
Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg
Time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data.
Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.
Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.
Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg
Time frame: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data.
Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.
Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
Time frame: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.
Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C
Time frame: Days 1, 7 and 14: pre-dose, 15 minutes post-dose
Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result.
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Time frame: Days 1, 7 and 14: 15 minutes post-dose
Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room.
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Time frame: Days 1, 7 and 14: 20 and 60 minutes post-dose
Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing.

3 secondary outcomes

Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg
Time frame: Up to Day 13
Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg
Time frame: Up to Day 13
Part 1: Number of Participants With Medical Device Incidents in CCI15106
Time frame: Up to Day 19

Results and safety

Results posted to the registry on 27 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Cohort A- CCI15106 60 mg SD	6	6
Part 1: Cohort A- CCI15106 120 mg SD	0	0
Part 1: Cohort A- CCI15106 30 mg BID	0	0
Part 1: Cohort A- Placebo	2	2
Part 1: Cohort B- CCI15106 60 mg BID	0	0
Part 1: Cohort B- Placebo	0	0
Part 1: Cohort C- Bystanders	0	0
Part 2: Cohort A- CCI15106 60 mg SD	0	0
Part 2: Cohort A- Placebo	0	0
Part 2: Cohort B- CCI15106 60 mg BID	0	0

Primary outcome: Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106

Time frame: Up to 51 days. Count of participants. Unit: Participants

Measure	Part 1: Cohort A- CCI15106 60 mg SD n = 6	Part 1: Cohort A- CCI15106 120 mg SD n = 6	Part 1: Cohort A- CCI15106 30 mg BID n = 6	Part 1: Cohort A- Placebo n = 2
NSAEs	0	0	0	0
SAEs	0	0	0	0

Population analysed: Safety Population.

Primary outcome: Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106

Time frame: Up to 46 days. Count of participants. Unit: Participants

Measure	Part 1: Cohort B- CCI15106 60 mg BID n = 12	Part 1: Cohort B- Placebo n = 2
NSAEs	6	0
SAEs	0	0

Population analysed: Safety Population.

Primary outcome: Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders

Time frame: Up to 46 days. Count of participants. Unit: Participants

Measure	Part 1: Cohort C- Bystanders n = 14
NSAEs	6
SAEs	0

Population analysed: Safety Population.

Primary outcome: Part 2 Cohort A: Number of Participants With NSAEs and SAEs

Time frame: Up to 33 days. Count of participants. Unit: Participants

Measure	Part 2: Cohort A- CCI15106 60 mg SD n = 6	Part 2: Cohort A- Placebo n = 2
NSAEs	0	0
SAEs	0	0

Population analysed: Safety Population.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Cohort A- CCI15106 60 mg SD	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part 1: Cohort A- CCI15106 120 mg SD	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part 1: Cohort A- CCI15106 30 mg BID	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part 1: Cohort A- Placebo	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Part 1: Cohort B- CCI15106 60 mg BID	0 of 12 (0%)	6 of 12 (50%)	0 of 12
Part 1: Cohort B- Placebo	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Part 1: Cohort C- Bystanders	0 of 14 (0%)	6 of 14 (42.9%)	0 of 14
Part 2: Cohort A- CCI15106 60 mg SD	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part 2: Cohort A- Placebo	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Part 2: Cohort B- CCI15106 60 mg BID	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32071044Dumont EF, Oliver AJ, Ioannou C, Billiard J, Dennison J, van den Berg F, Yang S, Chandrasekaran V, Young GC, Lahiry A, Starbuck DC, Harrell AW, Georgiou A, Hopchet N, Gillies A, Baker SJ. A Novel Inhaled Dry-Powder Formulation of Ribavirin Allows for Efficient Lung Delivery in Healthy Participants and Those with Chronic Obstructive Pulmonary Disease in a Phase 1 Study. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02267-19. doi: 10.1128/AAC.02267-19. Print 2020 Apr 21.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CCI15106 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106 (time frame: Up to 51 days). The study lists 72 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03235726, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.