Pulmonary Disease, Chronic ObstructivePhase 1NCT03189589

Safety, Tolerability and Pharmacokinetics (PK) Study of GSK2269557 in Healthy Subjects

A Phase 1 study testing GSK2269557 500 µg and GSK2269557 750 µg 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

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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?: GSK2269557 500 µg and GSK2269557 750 µg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited Kingdom
Study dates: 15 Jun 2017to 24 Jul 2017
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

Who may be able to join

Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG tests. Re-screening will be allowed once, at the discretion of the Principal Investigator in consultation with GlaxoSmithKline (GSK) medical monitor.
Normal spirometry at Screening FEV1 and FVC >=80 percent of predicted (measurements to be taken in triplicate and the highest value for each component must be >=80 percent of predicted).
Body weight >=50 kilograms (kg) and body mass index (BMI) within the range 18.0 - 35.0 kg per square meter (kg/m^2) (inclusive).
Male or female: A male subject must agree to use contraception during the treatment period for at least 5 half-lives plus 90 days after the last dose of study treatment and refrain from donating sperm during this period. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period for at least 5 half-lives plus 90 days after the last dose of study treatment.
Capable of giving signed informed consent.

Who cannot join

Asthma or a history of asthma (except in childhood, which has now remitted).
Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
Abnormal blood pressure [as determined by the investigator].
Alanine transaminase (ALT) >1.5 times upper limit of normal (ULN).
Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

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QTc interval >450 milliseconds (msec).
Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing.
Live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines during the study.
Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 56 days.
Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day. Consider adding the following criteria if subjects can only be enrolled once per study.
Current enrollment or past participation within the last 90 days before signing of consent in any other clinical study involving an investigational study treatment or any other type of medical research
Presence of Hepatitis B surface antigen (HBsAg) at screening Positive Hepatitis C antibody test result at screening. Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C Ribonucleic Acid (RNA) test is obtained.
Positive Hepatitis C RNA test result at screening or within 3 months prior to first dose of study treatment.
Positive pre-study drug/alcohol screen.
Positive human immunodeficiency virus (HIV) antibody test.
Regular use of known drugs of abuse.
Regular alcohol consumption within 3 months prior to the study defined as: An average weekly intake of >14 units for males and females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Current smoker or a history of smoking within 6 months of Screening, or a total pack year history of >5 pack years. [Number of pack years = (number of cigarettes per day/20) multiplied by number of years smoked]
Sensitivity to any of the study treatments, or components thereof (including lactose and MgSt), or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Cambridge, CB2 0GG

Other trials in United Kingdom

About this study

Official title: A Randomised, Double-blind, Parallel Group Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single Dose of GSK2269557 Administered Via the ELLIPTA™ Dry Powder Inhaler to Healthy Participants

GSK2269557 is being developed as an anti-inflammatory and anti-infective agent for the treatment of inflammatory airways diseases. This is the first study using a new formulation of GSK2269557 in healthy subjects and will evaluate the safety, tolerability and PK of a single dose of GSK2269557. Data derived from this study will inform on the PK profile and systemic exposure expected during Phase 2b. Approximately twelve healthy subjects will be randomized to receive a single dose of GSK2269557 750 micrograms (µg) or a single dose of GSK2269557 500 µg via the ELLIPTA® dry powder inhaler (DPI) formulated in a blend containing 0.4 percent magnesium stearate (MgSt) in 1:1 ratio. This randomized, parallel group study will be carried out in 3 phases, including screening phase, treatment phase and follow-up phase. The total study duration for each subject will be up to 6 weeks. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: GSK2269557 500 µg, GSK2269557 750 µg
Keywords: Pharmacokinetics, Healthy, ELLIPTA, Safety, GSK2269557, Inhalation, Tolerability
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration

What participants receive

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

GSK2269557 500 µgDrug
GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3 Kinase delta inhibitor. Single dose of GSK2269557 500 µg will be administered to randomized subjects via inhalation route using ELLIPTA DPI.
GSK2269557 750 µgDrug
GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3 Kinase delta inhibitor. Single dose of GSK2269557 750 µg will be administered to randomized subjects via inhalation route using ELLIPTA DPI.

Study groups in NCT03189589
Study group	Role	What they receive
GSK2269557 500 µg receivers	Experimental	Randomized healthy subjects will receive single dose of GSK2269557 500 µg via inhalation route via the ELLIPTA DPI. Receives: Drug: GSK2269557 500 µg
GSK2269557 750 µg receivers	Experimental	Randomized healthy subjects will receive single dose of GSK2269557 750 µg via inhalation route via the ELLIPTA DPI. Receives: Drug: GSK2269557 750 µg

What is being measured

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

Mean GSK2269557 Plasma Concentration
Whole blood samples of approximately 2 milliliters were collected for measurement of plasma concentrations of GSK2269557 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic (PK) Population which comprised of all randomized participants in the Safety Population and for whom a PK sample was obtained and analyzed.
Measured: Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose
Area Under the Plasma Drug Concentration Versus Time Curve (AUC) From Zero to Time t (AUC [0 to t]), AUC From Zero to 24 Hours (AUC [0 to 24]) and AUC From Zero to Infinity (AUC [0 to Inf]) of GSK2269557
Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.
Measured: Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose
Maximum Observed Plasma Drug Concentration (Cmax) and Concentration at Trough (Ctrough) of GSK2269557
Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Measured: Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose
Time to Maximum Observed Plasma Drug Concentration (Tmax) and Terminal Half-life (t1/2)
Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.
Measured: Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose

Secondary outcomes (6)

Number of Participants With Vital Signs of Potential Clinical Importance
Vital signs included blood pressure (systolic and diastolic blood pressure) and heart rate measurements and were assessed with the participant in a semi-supine position after 5 minutes rest. The potential clinical concern range values for vital signs were: systolic blood pressure (lower <85 millimeters of mercury and higher >160 millimeters of mercury), diastolic blood pressure (lower <45 millimeters of mercury and higher >100 millimeters of mercury) and heart rate (lower <40 beats per minute and higher >110 beats per minute). Number of participants with vital signs of potential clinical importance are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment.
Measured: Up to Day 2
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance
Twelve-lead ECG was obtained using an ECG machine which automatically measured PR, QRS, QT and corrected QT (QTc) intervals. ECG parameters and their potential clinical importance range values were: absolute QTc interval (lower >450 milliseconds [msec]), absolute PR interval (lower <110 msec and upper >220 msec), absolute QRS interval (lower <75 msec and upper >110 msec). Number of participants with electrocardiogram (ECG) values of potential clinical importance are presented.
Measured: Up to Day 2
Change From Baseline in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)
The maximal amount of air forcefully exhaled in 1 second (FEV1) and forced vital capacity (FVC) was measured using a spirometer. Baseline was latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline values from post-dose visit values. Mean change from Baseline in FVC and FEV1 is presented.
Measured: Baseline and Day 1
Number of Participants With Hematology Abnormalities of Potential Clinical Importance
Hematology parameters and their potential clinical concern values were: Hematocrit (high flag: >0.54 and change from Baseline: decrease of 0.075), hemoglobin (high flag: >180 grams per Liter and change from Baseline: decrease of 25 grams per Liter), lymphocytes (low flag: <0.8*10^9 cells per Liter), neutrophil count (low flag: <1.5*10^9 cells per Liter), platelet count (low flag: <100*10^9 cells per Liter and high flag: >550*10^9 cells per Liter) and white blood cell count (low flag: <3*10^9 cells per Liter and high flag: >20*10^9 cells per Liter). Number of participants with hematology abnormalities of potential clinical importance are presented.
Measured: Up to Day 2
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance
Clinical chemistry parameters and their potential clinical concern range values were: calcium (low flag <2 millimoles/Liter [mmol/L] and high flag >2.75 mmol/L), creatinine (high flag >44.2 micromoles/Liter increase in change from Baseline), glucose (fasting) (<3 mmol/L and >9 mmol/L), potassium (low flag <3 mmol/L and high flag >5.5 mmol/L above ULN), sodium (low flag <130 mmol/L and high flag >150 mmol/L). Number of participants with clinical chemistry abnormalities of potential clinical importance are presented.
Measured: Up to Day 2
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is 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, or is a congenital anomaly/birth defect or is medically significant.
Measured: Up to 12 days post-dose

Timeline

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

15 Jun 201724 Jul 2017

First posted16 Jun 2017
Study start15 Jun 2017
Primary completion24 Jul 2017
Study completion24 Jul 2017

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: Healthy subjects will be randomized to receive GSK2269557 750 µg or GSK2269557 500 µg.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03189589
Sponsor's protocol ID: 207674
Other IDs: 2017-001073-16, 2017
Status last verified: Aug 2019
First submitted: 14 Jun 2017
Last updated: 19 Aug 2019
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

Wilson R, Templeton A, Leemereise C, Eames R, Banham-Hall E, Hessel EM, Cahn A. Safety, Tolerability, and Pharmacokinetics of a New Formulation of Nemiralisib Administered via a Dry Powder Inhaler to Healthy Individuals. Clin Ther. 2019 Jun;41(6):1214-1220. doi: 10.1016/j.clinthera.2019.04.008. Epub 2019 May 7.
PubMed 31076203

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 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Parallel Group Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single Dose of GSK2269557 Administered Via the ELLIPTA™ Dry Powder Inhaler to Healthy Participants
ClinicalTrials.gov ID: NCT03189589
Acronym / sponsor ID: 207674
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pharmacokinetics, Healthy, ELLIPTA, Safety, GSK2269557, Inhalation, Tolerability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 15 Jun 2017 (actual)
Primary completion: 24 Jul 2017 (actual)
Study completion: 24 Jul 2017 (actual)
First posted: 16 Jun 2017 (actual)
Results: Posted 14 Jan 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: 2
Model description: Healthy subjects will be randomized to receive GSK2269557 750 µg or GSK2269557 500 µg.

Arm	Type	Receives
GSK2269557 500 µg receivers	Experimental	Drug: GSK2269557 500 µgRandomized healthy subjects will receive single dose of GSK2269557 500 µg via inhalation route via the ELLIPTA DPI.
GSK2269557 750 µg receivers	Experimental	Drug: GSK2269557 750 µgRandomized healthy subjects will receive single dose of GSK2269557 750 µg via inhalation route via the ELLIPTA DPI.

Who may qualify

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

Key inclusion criteria (6 listed)

Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG tests. Re-screening will be allowed once, at the discretion of the Principal Investigator in consultation with GlaxoSmithKline (GSK) medical monitor.
Normal spirometry at Screening FEV1 and FVC >=80 percent of predicted (measurements to be taken in triplicate and the highest value for each component must be >=80 percent of predicted).
Body weight >=50 kilograms (kg) and body mass index (BMI) within the range 18.0 - 35.0 kg per square meter (kg/m^2) (inclusive).
Male or female: A male subject must agree to use contraception during the treatment period for at least 5 half-lives plus 90 days after the last dose of study treatment and refrain from donating sperm during this period. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period for at least 5 half-lives plus 90 days after the last dose of study treatment.

Key exclusion criteria (20 listed)

Asthma or a history of asthma (except in childhood, which has now remitted).
Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
Abnormal blood pressure [as determined by the investigator].
Alanine transaminase (ALT) >1.5 times upper limit of normal (ULN).
Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).

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
GSK2269557 500 µgGSK2269557 is a potent and highly selective inhaled Phosphoinositide 3 Kinase delta inhibitor. Single dose of GSK2269557 500 µg will be administered to randomized subjects via inhalation route using ELLIPTA DPI.	Drug	GSK2269557 500 µg receivers
GSK2269557 750 µgGSK2269557 is a potent and highly selective inhaled Phosphoinositide 3 Kinase delta inhibitor. Single dose of GSK2269557 750 µg will be administered to randomized subjects via inhalation route using ELLIPTA DPI.	Drug	GSK2269557 750 µg receivers

Primary outcome

Mean GSK2269557 Plasma Concentration
Time frame: Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose
Whole blood samples of approximately 2 milliliters were collected for measurement of plasma concentrations of GSK2269557 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic (PK) Population which comprised of all randomized participants in the Safety Population and for whom a PK sample was obtained and analyzed.
Area Under the Plasma Drug Concentration Versus Time Curve (AUC) From Zero to Time t (AUC [0 to t]), AUC From Zero to 24 Hours (AUC [0 to 24]) and AUC From Zero to Infinity (AUC [0 to Inf]) of GSK2269557
Time frame: Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose
Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.
Maximum Observed Plasma Drug Concentration (Cmax) and Concentration at Trough (Ctrough) of GSK2269557
Time frame: Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose
Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Time to Maximum Observed Plasma Drug Concentration (Tmax) and Terminal Half-life (t1/2)
Time frame: Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose
Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.

6 secondary outcomes

Number of Participants With Vital Signs of Potential Clinical Importance
Time frame: Up to Day 2
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance
Time frame: Up to Day 2
Change From Baseline in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and Day 1
Number of Participants With Hematology Abnormalities of Potential Clinical Importance
Time frame: Up to Day 2
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance
Time frame: Up to Day 2
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: Up to 12 days post-dose

Results and safety

Results posted to the registry on 14 Jan 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
GSK2269557 500 mcg	6	6
GSK2269557 750 mcg	6	6

Primary outcome: Mean GSK2269557 Plasma Concentration

Time frame: Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose. Mean (Standard Deviation). Unit: Picograms per milliliter

Measure	GSK2269557 500 mcg n = 6	GSK2269557 750 mcg n = 6
Pre-dose	0.0 (0.00)	0.0 (0.00)
5 minutes post-dose	2175.5 (843.68)	1871.8 (985.15)
30 minutes post-dose	480.7 (155.28)	530.7 (260.82)
2 hours post-dose	322.9 (83.85)	414.6 (187.63)
6 hours post-dose	259.7 (81.60)	424.0 (186.51)
12 hours post-dose	210.5 (52.94)	319.5 (109.94)
24 hours post-dose	171.8 (48.71)	248.9 (71.92)
48 hours post-dose	114.0 (38.31)	145.2 (40.54)

Population analysed: PK Population.

Primary outcome: Area Under the Plasma Drug Concentration Versus Time Curve (AUC) From Zero to Time t (AUC [0 to t]), AUC From Zero to 24 Hours (AUC [0 to 24]) and AUC From Zero to Infinity (AUC [0 to Inf]) of GSK2269557

Measure	GSK2269557 500 mcg n = 6	GSK2269557 750 mcg n = 6
AUC (0 to t), n=6,6	14032.8 (5027.09)	18468.7 (7007.72)
AUC (0 to 24), n=6,6	6000.6 (1646.07)	8497.7 (3189.43)
AUC (0 to inf), n=4,5	19291.7 (3788.10)	23340.9 (6395.14)

Population analysed: PK Population.

Primary outcome: Maximum Observed Plasma Drug Concentration (Cmax) and Concentration at Trough (Ctrough) of GSK2269557

Measure	GSK2269557 500 mcg n = 6	GSK2269557 750 mcg n = 6
Cmax	2175.5 (843.68)	1871.8 (985.15)
Ctrough	171.8 (48.71)	248.9 (71.92)

Population analysed: PK Population.

Primary outcome: Time to Maximum Observed Plasma Drug Concentration (Tmax) and Terminal Half-life (t1/2)

Measure	GSK2269557 500 mcg n = 6	GSK2269557 750 mcg n = 6
Tmax, n=6,6	0.083 (0.08 to 0.10)	0.083 (0.07 to 0.083)
t1/2, n=4,5	42.7 (42 to 48)	38.2 (31 to 49)

Population analysed: PK Population.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 days post-dose. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK2269557 500 mcg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
GSK2269557 750 mcg	0 of 6 (0%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31076203Wilson R, Templeton A, Leemereise C, Eames R, Banham-Hall E, Hessel EM, Cahn A. Safety, Tolerability, and Pharmacokinetics of a New Formulation of Nemiralisib Administered via a Dry Powder Inhaler to Healthy Individuals. Clin Ther. 2019 Jun;41(6):1214-1220. doi: 10.1016/j.clinthera.2019.04.008. Epub 2019 May 7.
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 GSK2269557 500 µg and GSK2269557 750 µg 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 19 Aug 2019. 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?

Yes. Results are posted in the registry (first posted 14 Jan 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?

Mean GSK2269557 Plasma Concentration (time frame: Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose). The study lists 4 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 NCT03189589, 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 19 Aug 2019.