Pulmonary Disease, Chronic ObstructivePhase 1NCT03243760

Dose Escalating Study of CCI15106 Inhalation Capsules in Healthy Subjects and Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients

A Phase 1 study testing CCI15106 7.5 mg capsule in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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 7.5 mg capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited Kingdom
Study dates: 10 Feb 2016to 20 Aug 2016
Phase: Phase 1
Are there results?: None posted in the registry

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

Who may be able to join

For Healthy Subjects
Between 18 and 65 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the investigator.
Body weight >= 50 kilogram (kg) for males and 45 kg for females and body mass index (BMI) within the range 19 - 31 kg/meter square (m^2) (inclusive)
Male or Female: Male subjects with female partners of child bearing potential must comply with the contraception requirements as specified in protocol. A female subject is eligible to participate if she is of non-reproductive potential.
Capable of giving signed informed consent.

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For COPD Patients
Between 40 and 75 years of age inclusive, at the time of signing the informed consent.
Diagnosed with moderate COPD (GOLD class II) by a qualified physician as defined by the GOLD guidelines (http://www.goldcopd.org/).
The subject has spirometry at screening, showing: a) post-bronchodilator forced expiratory volume in 1 second (FEV1)>=50% and <80% predicted normal; b) post-bronchodilator FEV1/ forced vital capacity (FVC)<0.7.
Subject is a smoker or an ex-smoker.
Body weight >= 45 kg and BMI within the range 17 - 32 kg/m^2 (inclusive).
Male or Female: Male subjects with female partners of child bearing potential must comply with the contraception requirements as specified in protocol. A female subject is eligible to participate if she is of non-reproductive potential.
Capable of giving signed informed consent.

Who cannot join

For Healthy Subjects
Male partners of women who are pregnant or lactating
Alanine transaminase (ALT) and/or bilirubin >1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT interval corrected for heart rate (QTc )> 450 millisecond (msec).
Heart rate: <40 and >100 beats per minute (bpm) for males and <50 and >100 bpm for females, PR Interval: <120 and >220 msec, QRS duration: <70 and >120 msec, QTcF interval: >450 msec

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Any clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions.
Unable to refrain from prescription or non-prescription drugs
History of regular alcohol consumption within 3 months of the study
Breath test indicative of smoking at day -1
History of sensitivity to any of the study medications
For cohorts that will undergo BAL, contraindications to bronchoalveolar lavage
Documented lactose allergy/intolerance for cohorts with lactose placebo if they are used in the study.
Hemoglobin (Hgb) below the lower level of the normal range with one repeat testing allowed, or known hemoglobinopathies.
Known severe hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis, and erythema multiforme.
Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
A positive pre-study drug/alcohol screen.
A positive test for human immunodeficiency virus (HIV) antibody.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 month period.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
For COPD Patients
Male partners of women who are pregnant or lactating.
ALT and/or bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QTc > 450 msec or QTc > 480 msec in subjects with Bundle Branch Block.
Heart rate: <40 and >100 bpm for males and <50 and >100 bpm for females, PR Interval: <120 and >220 msec, QRS duration: <70 and >120 msec, QTcF interval: >450 msec
Subject has poorly controlled COPD as defined in protocol
History of an upper or lower respiratory tract infection requiring antibiotics in the 4 weeks prior to screening.
Subject has a diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, pulmonary fibrosis, asthma or any other respiratory condition that might, in the opinion of the Investigator, compromise the safety of the subject or affect the interpretation of the results.
Subjects who have 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.
Patients taking medications for any chronic conditions have to be on stable doses for 4 weeks prior to screening and until after completion of the treatment period. This includes COPD maintenance therapies (e.g. inhaled corticosteroids, long-acting beta-agonists, long-acting muscarinic agonists).
Didanosine and azathioprine are not allowed.
Use of short-acting inhaled bronchodilators is allowed, but patients must be able to discontinue their medications twice during the study.
Use of long-acting bronchodilators is allowed, but patients must be able to modify the schedule of their medications twice during the study.
Unable to refrain from smoking for 2 hour (h) prior to dosing and until all assessments are complete for 4 h after dosing and also for 1 h prior to any vital signs and ECG assessments.
History of regular alcohol consumption within 3 months of the study
History of sensitivity to any of the study medications.
Documented lactose allergy/intolerance
Impaired renal function (creatinine clearance < 50 mL/ minute).
Known severe hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis, and erythema multiforme.
Hgb below the lower level of the normal range with one repeat testing allowed or known hemoglobinopathies.
Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
A positive pre-study drug/alcohol screen.
A positive test for HIV antibody.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
London, NW10 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 Capsules for Inhalation in Healthy Subjects and Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD)

This study will be the first administration of CCI15106 capsules for inhalation to humans. The primary objective of the study is to investigate the safety and tolerability of single and repeat escalating doses of CCI15106 in healthy subjects and patients with moderate chronic obstructive pulmonary disease (COPD). The intention of this study is to provide sufficient confidence in the safety of the molecule delivered by inhalation to inform progression to further repeat dose and proof of concept studies.

This will be a three-part study. Part 1 will investigate single ascending doses and Part 2 repeat ascending doses in healthy subjects. In Part 3, a single dose will be administered to patients with moderate COPD.

There will be screening period of up to 30 days. The treatment period will be 3 days for Parts 1 and 3 and 16 days for Part 2. Follow-up will be performed within 30 days after the last dose.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: CCI15106 7.5 mg capsule, Placebo, Placebo-2
Keywords: CCI15106, pharmacokinetics, BAL, COPD
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.

CCI15106 7.5 mg capsuleDrug
Orange capsule containing a white to off-white powder, 21.4 mg of CCI15106: Trehalose:Trileucine 35/55/10 weight by weight (w/w)
PlaceboDrug
Orange capsule containing a white to off-white powder, 21.4 mg of Trehalose:Trileucine 85/15 w/w
Placebo-2Drug
Orange capsule containing a white to off-white powder, 21.4 mg of lactose. Placebo-2 to be used if unexpected safety signals are observed with the use of matching placebo.

Study groups in NCT03243760
Study group	Role	What they receive
Cohort A: Single dose CCI15106 7.5 mg /Placebo	Experimental	Healthy subjects will receive single dose of either 1 capsule CCI15106 7.5 milligram (mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. Receives: Drug: CCI15106 7.5 mg capsule; Drug: Placebo; Drug: Placebo-2
Cohort B: Single dose CCI15106 15 mg /Placebo	Experimental	Healthy subjects will receive single dose of either 15 mg CCI15106 (2 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. Receives: Drug: CCI15106 7.5 mg capsule; Drug: Placebo; Drug: Placebo-2
Cohort C: Single dose CCI15106 30 mg /Placebo	Experimental	Healthy subjects will receive single dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. Receives: Drug: CCI15106 7.5 mg capsule; Drug: Placebo; Drug: Placebo-2
Cohort D: Single dose CCI15106 30 mg /Placebo-BAL	Experimental	Healthy subjects will receive single dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. BAL procedures will be performed in this cohort additionally. Receives: Drug: CCI15106 7.5 mg capsule; Drug: Placebo; Drug: Placebo-2
Cohort E: Single dose CCI15106 45 mg /Placebo	Experimental	Healthy subjects will receive single dose of either 45 mg CCI15106 (6 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. Receives: Drug: CCI15106 7.5 mg capsule; Drug: Placebo; Drug: Placebo-2
Cohort F: Single dose CCI15106 60 mg /Placebo	Experimental	Healthy subjects will receive single dose of either 60 mg CCI15106 (8 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. Receives: Drug: CCI15106 7.5 mg capsule; Drug: Placebo; Drug: Placebo-2
Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days	Experimental	Healthy subjects will receive repeat dose of either 7.5 mg CCI15106 (1 capsule) or matching placebo twice daily (BID) for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. Receives: Drug: CCI15106 7.5 mg capsule; Drug: Placebo; Drug: Placebo-2
Cohort H: CCI15106 15 mg /Placebo BID 14 Days	Experimental	Healthy subjects will receive repeat dose of either 15 mg CCI15106 (2 capsules of 7.5 mg) or matching placebo BID for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. Receives: Drug: CCI15106 7.5 mg capsule; Drug: Placebo; Drug: Placebo-2
Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL	Experimental	Healthy subjects will receive repeat dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo BID for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. BAL procedures will be performed in this cohort additionally. Receives: Drug: CCI15106 7.5 mg capsule; Drug: Placebo; Drug: Placebo-2
Cohort J: CCI15106 =<30 mg /Placebo BID 14 Days	Experimental	Healthy subjects will receive repeat dose of either =< 30 mg CCI15106 (less than or equal to 4 capsules of 7.5 mg) or matching placebo BID for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. The dose for cohort J is unknown at this time and will depend on results seen in the previous cohorts. Receives: Drug: CCI15106 7.5 mg capsule; Drug: Placebo; Drug: Placebo-2
Cohort K: Single dose CCI15106 30 mg /Placebo-COPD	Experimental	COPD patients will receive single dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. Receives: Drug: CCI15106 7.5 mg capsule; Drug: Placebo; Drug: Placebo-2

What is being measured

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

Part 1: Number of participants with adverse events (AE)
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.
Measured: Up to 33 days
Part 2: Number of participants with AE
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.
Measured: Up to 46 days
Part 3: Number of participants with AE
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.
Measured: Up to 33 days
Part 1: Number of subjects with abnormal clinical hematology test findings
Hematology tests will be performed as a measure of safety
Measured: Up to 33 days
Part 2: Number of subjects with abnormal clinical hematology test findings
Hematology tests will be performed as a measure of safety
Measured: Up to 46 days
Part 3: Number of subjects with abnormal clinical hematology test findings
Hematology tests will be performed as a measure of safety
Measured: Up to 33 days
Part 1: Number of subjects with abnormal clinical chemistry test findings
Clinical chemistry laboratory tests will be performed as a measure of safety
Measured: Up to 33 days
Part 2: Number of subjects with abnormal clinical chemistry test findings
Clinical chemistry laboratory tests will be performed as a measure of safety
Measured: Up to 46 days
Part 3: Number of subjects with abnormal clinical chemistry test findings
Clinical chemistry laboratory tests will be performed as a measure of safety
Measured: Up to 33 days
Part 1: Number of subjects with abnormal urine analysis test findings
Urine analysis tests will be performed as a measure of safety
Measured: Up to 33 days
Part 2: Number of subjects with abnormal urine analysis test findings
Urine analysis tests will be performed as a measure of safety
Measured: Up to 46 days
Part 3: Number of subjects with abnormal urine analysis test findings
Urine analysis tests will be performed as a measure of safety
Measured: Up to 33 days
Part 1: Number of subjects with abnormal findings of body temperature
Body temperature will be measured in a semi-supine position after 5 minutes of rest
Measured: Up to 33 days
Part 2: Number of subjects with abnormal findings of body temperature
Body temperature will be measured in a semi-supine position after 5 minutes of rest
Measured: Up to 46 days
Part 3: Number of subjects with abnormal findings of body temperature
Body temperature will be measured in a semi-supine position after 5 minutes of rest
Measured: Up to 33 days
Part 1: Number of subjects with abnormal blood pressure values
Systolic and diastolic blood pressure values will be measured in a semi-supine position after 5 minutes of rest
Measured: Up to 33 days
Part 2: Number of subjects with abnormal blood pressure values
Systolic and diastolic blood pressure values will be measured in a semi-supine position after 5 minutes of rest
Measured: Up to 46 days
Part 3: Number of subjects with abnormal blood pressure values
Systolic and diastolic blood pressure values will be measured in a semi-supine position after 5 minutes of rest
Measured: Up to 33 days
Part 1: Number of subjects with abnormal pulse rate values
Pulse rate will be measured in a semi-supine position after 5 minutes of rest
Measured: Up to 33 days
Part 2: Number of subjects with abnormal pulse rate values
Pulse rate will be measured in a semi-supine position after 5 minutes of rest
Measured: Up to 46 days
Part 3: Number of subjects with abnormal pulse rate values
Pulse rate will be measured in a semi-supine position after 5 minutes of rest
Measured: Up to 33 days
Part 1: Number of subjects with abnormal respiratory rate values
Respiratory rate will be measured in a semi-supine position after 5 minutes of rest
Measured: Up to 33 days
Part 2: Number of subjects with abnormal respiratory rate values
Respiratory rate will be measured in a semi-supine position after 5 minutes of rest
Measured: Up to 46 days
Part 3: Number of subjects with abnormal respiratory rate values
Respiratory rate will be measured in a semi-supine position after 5 minutes of rest
Measured: Up to 33 days
Part 1: Number of subjects with abnormal electrocardiogram (ECG) findings
12-lead ECG will be obtained during the study in semi-supine position after 5 minutes rest.
Measured: Up to 33 days
Part 2: Number of subjects with abnormal ECG findings
12-lead ECG will be obtained during the study in semi-supine position after 5 minutes rest.
Measured: Up to 46 days
Part 3: Number of subjects with abnormal ECG findings
12-lead ECG will be obtained during the study in semi-supine position after 5 minutes rest.
Measured: Up to 33 days
Part 1: Number of subjects with abnormal Telemetry findings
Cardiac telemetry will be performed continuously till 4hour post morning dose.
Measured: Up to 33 days
Part 2: Number of subjects with abnormal telemetry findings
Cardiac telemetry will be performed continuously till 4hour post morning dose.
Measured: Up to 46 days
Part 3: Number of subjects with abnormal telemetry findings
Cardiac telemetry will be performed continuously till 4hour post morning dose.
Measured: Up to 33 days
Part 1: Number of subjects with abnormal spirometry findings
Spirometry is a test to diagnose lung conditions. Spirometry will be performed at selected time points during the study.
Measured: Up to 4 hour post-dose
Part 2: Number of subjects with abnormal spirometry findings
Spirometry is a test to diagnose lung conditions. Spirometry will be performed at selected time points during the study.
Measured: Up to 14 days
Part 3: Number of subjects with abnormal spirometry findings
Spirometry is a test to diagnose lung conditions. Spirometry will be performed at selected time points during the study.
Measured: Up to 4 hour post dose
Part 1: Area under the curve (AUC) from time zero to infinity (AUC[0-inf] following single dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate AUC(0-inf) of drug
Measured: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Part 3: AUC[0-inf] following single dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate AUC(0-inf) of drug
Measured: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Part 1: AUC from time zero to the time of last quantifiable concentration (AUC[0-last]) following single dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate AUC(0-last) of drug
Measured: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Part 3: AUC[0-last] following single dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate AUC(0-last) of drug
Measured: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Part 1: Maximum plasma concentration (Cmax) following single dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate Cmax of drug
Measured: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Part 2: Cmax following repeat dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate Cmax of drug
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 hours post dose on Day 1 and 14; Pre-dose on Day 2-12 and on follow-up
Part 3: Cmax following single dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate Cmax of drug
Measured: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Part 1: time of maximum concentration (Tmax) following single dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate Tmax of drug
Measured: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Part 2: Tmax following repeat dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate Tmax of drug
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 hours post dose on Day 1 and 14; Pre-dose on Day 2-12 and on follow-up
Part 3: Tmax following single dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate Tmax of drug
Measured: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Part 1: Elimination half life (T1/2) following single dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate T1/2 of drug
Measured: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Part 3: T1/2 following single dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate T1/2 of drug
Measured: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Part 1: Clearance (CL/F) following single dose administration of CCI15106
Clearance will be calculated from concentration-time curve based on each individual subject's profile.
Measured: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
part 3: CL/F following single dose administration of CCI15106
Clearance will be calculated from concentration-time curve based on each individual subject's profile.
Measured: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Part 2: AUC from time zero to end of dosing interval (AUC[0-tau]) following repeat dose administration of CCI15106
Blood samples will be collected at specific time points to evaluate AUC(0-tau) of drug
Measured: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 hours post dose on Day 1 and 14; Pre-dose on Day 2-12 and on follow-up

Secondary outcomes (5)

Part 1 Concentrations of CCI15106 in ELF and BAL cell pellet
BAL samples will be collected for assessing concentrations of CCI15106 in lung epithelial lining fluid (ELF) and bronchoalveolar lavage (BAL) cell pellet in cohort D.
Measured: Up to 2 hour post-dose
Part 2: Concentrations of CCI15106 in ELF and BAL cell pellet
BAL samples will be collected for assessing concentrations of CCI15106 in lung ELF and BAL cell pellet in cohort I.
Measured: Up to 13 days
Part 1: Number of medical device incidents
Device incident is malfunction or deterioration in 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 patient/user/other person or to a serious deterioration in their state of health. Device incident assessment will be done at the time of each dosing to investigate the performance of the Modified Air Inlet Rotahaler™ device.
Measured: Day 1
Part 2: Number of medical device incidents
Device incident is malfunction or deterioration in 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 patient/user/other person or to a serious deterioration in their state of health. Device incident assessment will be done at the time of each dosing to investigate the performance of the Modified Air Inlet Rotahaler™ device.
Measured: Up to 14 days
Part 3: Number of medical device incidents
Device incident is malfunction or deterioration in 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 patient/user/other person or to a serious deterioration in their state of health. Device incident assessment will be done at the time of each dosing to investigate the performance of the Modified Air Inlet Rotahaler™ device.
Measured: Day 1

Timeline

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

10 Feb 201620 Aug 2016

First posted9 Aug 2017
Study start10 Feb 2016
Primary completion20 Jul 2016
Study completion20 Aug 2016

Why it stopped: The trial is terminated before investigation of repeat escalating doses as these will be conducted with the new formulation instead.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03243760
Sponsor's protocol ID: 202031
Other IDs: 2015-003960-35, 2015
Status last verified: Jun 2020
First submitted: 31 Jul 2017
Last updated: 30 Jun 2020
Results posted: No
Data monitoring committee: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 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 Capsules for Inhalation in Healthy Subjects and Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT03243760
Acronym / sponsor ID: 202031
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: CCI15106, pharmacokinetics, BAL, COPD
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The trial is terminated before investigation of repeat escalating doses as these will be conducted with the new formulation instead.
Enrolment: 60 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 10 Feb 2016 (actual)
Primary completion: 20 Jul 2016 (actual)
Study completion: 20 Aug 2016 (actual)
First posted: 9 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

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

There will be screening period of up to 30 days. The treatment period will be 3 days for Parts 1 and 3 and 16 days for Part 2. Follow-up will be performed within 30 days after the last dose.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 11

Arm	Type	Receives
Cohort A: Single dose CCI15106 7.5 mg /Placebo	Experimental	Drug: CCI15106 7.5 mg capsule, Drug: Placebo, Drug: Placebo-2Healthy subjects will receive single dose of either 1 capsule CCI15106 7.5 milligram (mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
Cohort B: Single dose CCI15106 15 mg /Placebo	Experimental	Drug: CCI15106 7.5 mg capsule, Drug: Placebo, Drug: Placebo-2Healthy subjects will receive single dose of either 15 mg CCI15106 (2 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
Cohort C: Single dose CCI15106 30 mg /Placebo	Experimental	Drug: CCI15106 7.5 mg capsule, Drug: Placebo, Drug: Placebo-2Healthy subjects will receive single dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
Cohort D: Single dose CCI15106 30 mg /Placebo-BAL	Experimental	Drug: CCI15106 7.5 mg capsule, Drug: Placebo, Drug: Placebo-2Healthy subjects will receive single dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. BAL procedures will be performed in this cohort additionally.
Cohort E: Single dose CCI15106 45 mg /Placebo	Experimental	Drug: CCI15106 7.5 mg capsule, Drug: Placebo, Drug: Placebo-2Healthy subjects will receive single dose of either 45 mg CCI15106 (6 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
Cohort F: Single dose CCI15106 60 mg /Placebo	Experimental	Drug: CCI15106 7.5 mg capsule, Drug: Placebo, Drug: Placebo-2Healthy subjects will receive single dose of either 60 mg CCI15106 (8 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days	Experimental	Drug: CCI15106 7.5 mg capsule, Drug: Placebo, Drug: Placebo-2Healthy subjects will receive repeat dose of either 7.5 mg CCI15106 (1 capsule) or matching placebo twice daily (BID) for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
Cohort H: CCI15106 15 mg /Placebo BID 14 Days	Experimental	Drug: CCI15106 7.5 mg capsule, Drug: Placebo, Drug: Placebo-2Healthy subjects will receive repeat dose of either 15 mg CCI15106 (2 capsules of 7.5 mg) or matching placebo BID for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.
Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL	Experimental	Drug: CCI15106 7.5 mg capsule, Drug: Placebo, Drug: Placebo-2Healthy subjects will receive repeat dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo BID for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. BAL procedures will be performed in this cohort additionally.
Cohort J: CCI15106 =<30 mg /Placebo BID 14 Days	Experimental	Drug: CCI15106 7.5 mg capsule, Drug: Placebo, Drug: Placebo-2Healthy subjects will receive repeat dose of either =< 30 mg CCI15106 (less than or equal to 4 capsules of 7.5 mg) or matching placebo BID for 14 days by inhalation via Modified Air Inlet Rotahaler™ device according to randomization. The dose for cohort J is unknown at this time and will depend on results seen in the previous cohorts.
Cohort K: Single dose CCI15106 30 mg /Placebo-COPD	Experimental	Drug: CCI15106 7.5 mg capsule, Drug: Placebo, Drug: Placebo-2COPD patients will receive single dose of either 30 mg CCI15106 (4 capsules of 7.5 mg) or matching placebo by inhalation via Modified Air Inlet Rotahaler™ device according to randomization.

Who may qualify

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

Key inclusion criteria (14 listed)

For Healthy Subjects
Between 18 and 65 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the investigator.
Body weight >= 50 kilogram (kg) for males and 45 kg for females and body mass index (BMI) within the range 19 - 31 kg/meter square (m^2) (inclusive)
Male or Female: Male subjects with female partners of child bearing potential must comply with the contraception requirements as specified in protocol. A female subject is eligible to participate if she is of non-reproductive potential.

Key exclusion criteria (49 listed)

For Healthy Subjects
Male partners of women who are pregnant or lactating
Alanine transaminase (ALT) and/or bilirubin >1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT interval corrected for heart rate (QTc )> 450 millisecond (msec).

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
CCI15106 7.5 mg capsuleOrange capsule containing a white to off-white powder, 21.4 mg of CCI15106: Trehalose:Trileucine 35/55/10 weight by weight (w/w)	Drug	Cohort A: Single dose CCI15106 7.5 mg /Placebo, Cohort B: Single dose CCI15106 15 mg /Placebo, Cohort C: Single dose CCI15106 30 mg /Placebo, Cohort D: Single dose CCI15106 30 mg /Placebo-BAL, Cohort E: Single dose CCI15106 45 mg /Placebo, Cohort F: Single dose CCI15106 60 mg /Placebo, Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days, Cohort H: CCI15106 15 mg /Placebo BID 14 Days, Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL, Cohort J: CCI15106 =<30 mg /Placebo BID 14 Days, Cohort K: Single dose CCI15106 30 mg /Placebo-COPD
PlaceboOrange capsule containing a white to off-white powder, 21.4 mg of Trehalose:Trileucine 85/15 w/w	Drug	Cohort A: Single dose CCI15106 7.5 mg /Placebo, Cohort B: Single dose CCI15106 15 mg /Placebo, Cohort C: Single dose CCI15106 30 mg /Placebo, Cohort D: Single dose CCI15106 30 mg /Placebo-BAL, Cohort E: Single dose CCI15106 45 mg /Placebo, Cohort F: Single dose CCI15106 60 mg /Placebo, Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days, Cohort H: CCI15106 15 mg /Placebo BID 14 Days, Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL, Cohort J: CCI15106 =<30 mg /Placebo BID 14 Days, Cohort K: Single dose CCI15106 30 mg /Placebo-COPD
Placebo-2Orange capsule containing a white to off-white powder, 21.4 mg of lactose. Placebo-2 to be used if unexpected safety signals are observed with the use of matching placebo.	Drug	Cohort A: Single dose CCI15106 7.5 mg /Placebo, Cohort B: Single dose CCI15106 15 mg /Placebo, Cohort C: Single dose CCI15106 30 mg /Placebo, Cohort D: Single dose CCI15106 30 mg /Placebo-BAL, Cohort E: Single dose CCI15106 45 mg /Placebo, Cohort F: Single dose CCI15106 60 mg /Placebo, Cohort G: CCI15106 7.5 mg /Placebo BID 14 Days, Cohort H: CCI15106 15 mg /Placebo BID 14 Days, Cohort I: CCI15106 30 mg /Placebo BID 14 Days-BAL, Cohort J: CCI15106 =<30 mg /Placebo BID 14 Days, Cohort K: Single dose CCI15106 30 mg /Placebo-COPD

Primary outcome

Part 1: Number of participants with adverse events (AE)
Time frame: Up to 33 days
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.
Part 2: Number of participants with AE
Time frame: Up to 46 days
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.
Part 3: Number of participants with AE
Time frame: Up to 33 days
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE will be collected from the start of study treatment until the final follow-up visit.
Part 1: Number of subjects with abnormal clinical hematology test findings
Time frame: Up to 33 days
Hematology tests will be performed as a measure of safety
Part 2: Number of subjects with abnormal clinical hematology test findings
Time frame: Up to 46 days
Hematology tests will be performed as a measure of safety
Part 3: Number of subjects with abnormal clinical hematology test findings
Time frame: Up to 33 days
Hematology tests will be performed as a measure of safety
Part 1: Number of subjects with abnormal clinical chemistry test findings
Time frame: Up to 33 days
Clinical chemistry laboratory tests will be performed as a measure of safety
Part 2: Number of subjects with abnormal clinical chemistry test findings
Time frame: Up to 46 days
Clinical chemistry laboratory tests will be performed as a measure of safety
Part 3: Number of subjects with abnormal clinical chemistry test findings
Time frame: Up to 33 days
Clinical chemistry laboratory tests will be performed as a measure of safety
Part 1: Number of subjects with abnormal urine analysis test findings
Time frame: Up to 33 days
Urine analysis tests will be performed as a measure of safety
Part 2: Number of subjects with abnormal urine analysis test findings
Time frame: Up to 46 days
Urine analysis tests will be performed as a measure of safety
Part 3: Number of subjects with abnormal urine analysis test findings
Time frame: Up to 33 days
Urine analysis tests will be performed as a measure of safety
Part 1: Number of subjects with abnormal findings of body temperature
Time frame: Up to 33 days
Body temperature will be measured in a semi-supine position after 5 minutes of rest
Part 2: Number of subjects with abnormal findings of body temperature
Time frame: Up to 46 days
Body temperature will be measured in a semi-supine position after 5 minutes of rest
Part 3: Number of subjects with abnormal findings of body temperature
Time frame: Up to 33 days
Body temperature will be measured in a semi-supine position after 5 minutes of rest
Part 1: Number of subjects with abnormal blood pressure values
Time frame: Up to 33 days
Systolic and diastolic blood pressure values will be measured in a semi-supine position after 5 minutes of rest
Part 2: Number of subjects with abnormal blood pressure values
Time frame: Up to 46 days
Systolic and diastolic blood pressure values will be measured in a semi-supine position after 5 minutes of rest
Part 3: Number of subjects with abnormal blood pressure values
Time frame: Up to 33 days
Systolic and diastolic blood pressure values will be measured in a semi-supine position after 5 minutes of rest
Part 1: Number of subjects with abnormal pulse rate values
Time frame: Up to 33 days
Pulse rate will be measured in a semi-supine position after 5 minutes of rest
Part 2: Number of subjects with abnormal pulse rate values
Time frame: Up to 46 days
Pulse rate will be measured in a semi-supine position after 5 minutes of rest
Part 3: Number of subjects with abnormal pulse rate values
Time frame: Up to 33 days
Pulse rate will be measured in a semi-supine position after 5 minutes of rest
Part 1: Number of subjects with abnormal respiratory rate values
Time frame: Up to 33 days
Respiratory rate will be measured in a semi-supine position after 5 minutes of rest
Part 2: Number of subjects with abnormal respiratory rate values
Time frame: Up to 46 days
Respiratory rate will be measured in a semi-supine position after 5 minutes of rest
Part 3: Number of subjects with abnormal respiratory rate values
Time frame: Up to 33 days
Respiratory rate will be measured in a semi-supine position after 5 minutes of rest
Part 1: Number of subjects with abnormal electrocardiogram (ECG) findings
Time frame: Up to 33 days
12-lead ECG will be obtained during the study in semi-supine position after 5 minutes rest.
Part 2: Number of subjects with abnormal ECG findings
Time frame: Up to 46 days
12-lead ECG will be obtained during the study in semi-supine position after 5 minutes rest.
Part 3: Number of subjects with abnormal ECG findings
Time frame: Up to 33 days
12-lead ECG will be obtained during the study in semi-supine position after 5 minutes rest.
Part 1: Number of subjects with abnormal Telemetry findings
Time frame: Up to 33 days
Cardiac telemetry will be performed continuously till 4hour post morning dose.
Part 2: Number of subjects with abnormal telemetry findings
Time frame: Up to 46 days
Cardiac telemetry will be performed continuously till 4hour post morning dose.
Part 3: Number of subjects with abnormal telemetry findings
Time frame: Up to 33 days
Cardiac telemetry will be performed continuously till 4hour post morning dose.
Part 1: Number of subjects with abnormal spirometry findings
Time frame: Up to 4 hour post-dose
Spirometry is a test to diagnose lung conditions. Spirometry will be performed at selected time points during the study.
Part 2: Number of subjects with abnormal spirometry findings
Time frame: Up to 14 days
Spirometry is a test to diagnose lung conditions. Spirometry will be performed at selected time points during the study.
Part 3: Number of subjects with abnormal spirometry findings
Time frame: Up to 4 hour post dose
Spirometry is a test to diagnose lung conditions. Spirometry will be performed at selected time points during the study.
Part 1: Area under the curve (AUC) from time zero to infinity (AUC[0-inf] following single dose administration of CCI15106
Time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Blood samples will be collected at specific time points to evaluate AUC(0-inf) of drug
Part 3: AUC[0-inf] following single dose administration of CCI15106
Time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Blood samples will be collected at specific time points to evaluate AUC(0-inf) of drug
Part 1: AUC from time zero to the time of last quantifiable concentration (AUC[0-last]) following single dose administration of CCI15106
Time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Blood samples will be collected at specific time points to evaluate AUC(0-last) of drug
Part 3: AUC[0-last] following single dose administration of CCI15106
Time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Blood samples will be collected at specific time points to evaluate AUC(0-last) of drug
Part 1: Maximum plasma concentration (Cmax) following single dose administration of CCI15106
Time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Blood samples will be collected at specific time points to evaluate Cmax of drug
Part 2: Cmax following repeat dose administration of CCI15106
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 hours post dose on Day 1 and 14; Pre-dose on Day 2-12 and on follow-up
Blood samples will be collected at specific time points to evaluate Cmax of drug
Part 3: Cmax following single dose administration of CCI15106
Time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Blood samples will be collected at specific time points to evaluate Cmax of drug
Part 1: time of maximum concentration (Tmax) following single dose administration of CCI15106
Time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Blood samples will be collected at specific time points to evaluate Tmax of drug
Part 2: Tmax following repeat dose administration of CCI15106
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 hours post dose on Day 1 and 14; Pre-dose on Day 2-12 and on follow-up
Blood samples will be collected at specific time points to evaluate Tmax of drug
Part 3: Tmax following single dose administration of CCI15106
Time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Blood samples will be collected at specific time points to evaluate Tmax of drug
Part 1: Elimination half life (T1/2) following single dose administration of CCI15106
Time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Blood samples will be collected at specific time points to evaluate T1/2 of drug
Part 3: T1/2 following single dose administration of CCI15106
Time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Blood samples will be collected at specific time points to evaluate T1/2 of drug
Part 1: Clearance (CL/F) following single dose administration of CCI15106
Time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Clearance will be calculated from concentration-time curve based on each individual subject's profile.
part 3: CL/F following single dose administration of CCI15106
Time frame: Pre dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 hour post-dose and on follow-up
Clearance will be calculated from concentration-time curve based on each individual subject's profile.
Part 2: AUC from time zero to end of dosing interval (AUC[0-tau]) following repeat dose administration of CCI15106
Time frame: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 hours post dose on Day 1 and 14; Pre-dose on Day 2-12 and on follow-up
Blood samples will be collected at specific time points to evaluate AUC(0-tau) of drug

5 secondary outcomes

Part 1 Concentrations of CCI15106 in ELF and BAL cell pellet
Time frame: Up to 2 hour post-dose
Part 2: Concentrations of CCI15106 in ELF and BAL cell pellet
Time frame: Up to 13 days
Part 1: Number of medical device incidents
Time frame: Day 1
Part 2: Number of medical device incidents
Time frame: Up to 14 days
Part 3: Number of medical device incidents
Time frame: Day 1

Results and safety

The study was stopped early (reason given: The trial is terminated before investigation of repeat escalating doses as these will be conducted with the new formulation instead.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
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.

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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 7.5 mg capsule 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?

The sponsor lists 14 inclusion and 49 exclusion criteria. 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: stopped early, as of the sponsor's last update on 30 Jun 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. 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?

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: Number of participants with adverse events (AE) (time frame: Up to 33 days). The study lists 48 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 NCT03243760, 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 30 Jun 2020.