Pulmonary Disease, Chronic ObstructivePhase 1NCT01762878
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of the Dry Powder Formulation of GSK2269557 in Healthy Subjects
A Phase 1 study testing GSK2269557 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
GSK2269557 is potent and highly selective inhaled phosphoinositides 3-kinases -delta (PI3K-delta) inhibitor being developed as an anti-inflammatory agent for the treatment of inflammatory airway diseases. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK2269557
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jan 2013to 21 Oct 2013
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who are current daily cigarette smokers. Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of >= 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked
- Normal spirometry (FEV1 >= 80% of predicted) at screening.
- Single QTcF < 450 milliseconds (msec); or QTcF< 480 msec in subjects with Right Bundle Branch Block
- Currently healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac testing. A subject with a clinical abnormality or laboratory parameters outside the reference range expected for them and the population being studied may be included only if the Investigator believes that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or outcomes
- Between 18 and 50 years of age inclusive, at the time of signing the informed consent
- A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented hysterectomy, bilateral oophorectomy or bilateral salpingectomy or postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods f they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method
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- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods.
- Body weight >= 50 kilogram (kg) and body mass index (BMI) within the range 18 to 31 kg/meter^2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Who cannot join
- Subjects who are unable to produce a total weight of at least 0.100 grams (g) of selected sputum at screening
- Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded include, but are not limited to pipes and cigars
- Urinary cotinine levels at screening < 30 nanograms (ng)/mL
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- A history of congestive heart failure, coronary insufficiency or clinically significant cardiac arrhythmia that would contraindicate the subject's participation in the study
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- A positive pre-study drug/alcohol screen
- A positive test for HIV antibody
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint ( approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits
- 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: 90 days, 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
- Unable to refrain from the use of prescription or non-prescription drugs (except simple analgesics), including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GlaxoSmithKline (GSK) Medical Monitor the medication will not interfere with the study procedures or compromise subject safety
- The subject has received any type of vaccination within 4 weeks of their first dose of investigational product, or are expected to be vaccinated within 4 weeks after their last dose of investigational product
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 90 day period
- Unwillingness or inability to follow the procedures outlined in the protocol
- Subject is mentally or legally incapacitated
- Subjects who have asthma or a history of asthma (except in childhood and which has now remitted)
- Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids from 7 days prior to the first and subsequent doses of study medication and until collection of the last PK sample for that study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Centre, Double-Blind, Placebo Controlled Two Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of GSK2269557 as a Dry Powder in Healthy Subjects Who Smoke Cigarettes
GSK2269557 is potent and highly selective inhaled phosphoinositides 3-kinases -delta (PI3K-delta) inhibitor being developed as an anti-inflammatory agent for the treatment of inflammatory airway diseases. GSK2269557 has already been administered as a nebulized solution in single and repeat doses to humans and has been well tolerated across the range of doses used. The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and repeat inhaled doses of GSK2269557 as a dry powder. This study is the first administration of dry powder GSK2269557 in humans.
Part A will consist of four treatment periods separated by at least 14 days wash out periods. In each treatment period there will be 12 subjects receiving GSK2269557 and 4 subjects receiving placebo. The doses of GSK2269557 planned for Part A are 100 micrograms (mcg), 500 mcg and 3000 mcg. Blinded safety and available pharmacokinetic (PK) data will be reviewed before each dose escalation. Part B will be a parallel group design conducted in a separate group of subjects from Part A. Nine subjects will receive repeat doses of GSK2269557 and 3 subjects will receive repeat doses of placebo for 14 days. The total daily dose will be the same as the dose that was well tolerated in Part A. The study duration, including screening and follow-up, is not expected to exceed 82 days for subjects in part A and 55 days for subjects in part B of the study.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK2269557, Placebo
- Keywords
- pharmacodynamics, pharmacokinetics, healthy volunteers, Pi3K-delta, GSK2269557, safety, dry powder inhaler
- 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.
GSK2269557Drug
Dry powder for oral inhalation (100 and 500 mcg /blister) once daily using DIKUS device. The doses of GSK2269557 planned for Part A are: 100 mcg, 500 mcg and 3000 mcg
PlaceboDrug
Dry powder for oral inhalation once daily using DIKUS device
| Study group | Role | What they receive |
|---|---|---|
| GSK2269557 100 mcg arm | Experimental | Each subject will receive 4 treatments in 4 treatment periods in Part A of the study. Subjects in this arm will be randomized to receive GSK2269557 100 mcg in one of the 4 treatment periods. Receives: Drug: GSK2269557 |
| GSK2269557 500 mcg arm | Experimental | Each subject will undergo 4 treatments in 4 treatment periods in Part A of the study. Subjects in this arm will be randomized to receive GSK2269557 500 mcg in one of the 4 treatment periods Receives: Drug: GSK2269557 |
| GSK2269557 3000 mcg arm | Experimental | Each subject will undergo 4 treatments in 4 treatment periods in Part A of the study. Subjects in this arm will be randomized to receive GSK2269557 3000 mcg in one of the 4 treatment periods Receives: Drug: GSK2269557 |
| Placebo arm | Placebo comparator | The subjects will receive single dose of placebo in each treatment period of part A and repeat doses of placebo in Part B of the study. Receives: Drug: Placebo |
| Part B GSK2269557 arm | Experimental | The selection of total daily doses of GSK2269557 for Part B will anticipated to be the maximum well tolerated dose selected from Part A. The subjects will receive GSK2269557 in ratio of 3:1.with placebo. If the dose selected for Part B is not well tolerated on repeat dosing the dose may be reduced during Part B or given as divided doses. Receives: Drug: GSK2269557 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single ascending doses assessed by clinical monitoring of blood pressure
Blood pressure measurement will include systolic and diastolic blood pressure measured after resting in the supine position for 5 minutes
Measured: up to 52 days
Safety and tolerability of repeat doses assessed by clinical monitoring of blood pressure
Pulse rate measurement should be done after resting in the supine position for 5 minutes
Measured: up to 24 days
Safety and tolerability of single ascending doses assessed by pulse rate
Pulse rate measurement should be done after resting in the supine position for 5 minutes
Measured: up to 52 days
Safety and tolerability of repeat doses assessed by pulse rate
Pulse rate measurement should be done after resting in the supine position for 5 minutes
Measured: up to 24 days
Safety and tolerability of single ascending doses assessed by spirometry (FEV1)
Pulmonary function test measured from forced expiratory volume in 1 second (FEV1). Pulmonary function test will be repeated until three technically acceptable measurements have been made.
Measured: up to 52 days
Safety and tolerability of repeat doses assessed by spirometry
Pulmonary function test measured from FEV1. Pulmonary function test will be repeated until three technically acceptable measurements have been made.
Measured: up to 24 days
Safety and tolerability of single ascending doses assessed by Electrocardiogram (ECG)
12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT duration corrected for heart rate by Bazett's formula (QTcB)/ QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. ECGs will be measured after resting in supine position for 5 minutes
Measured: up to 52 days
Safety and tolerability of repeat doses assessed by ECG
12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcB/QTcF intervals. ECGs will be measured after resting in supine position for 5 minutes
Measured: up to 24 days
Safety and tolerability of single ascending doses assessed by clinical laboratory test
Clinical laboratory test includes hematology, clinical chemistry, urinalysis and additional parameters
Measured: up to 52 days
Safety and tolerability of repeat doses assessed by clinical laboratory test
Clinical laboratory test includes hematology, clinical chemistry, urinalysis and additional parameters
Measured: up to 24 days
Safety and tolerability of single ascending doses assessed by number of subjects with adverse events (AEs)
AEs will be collected from the start of study treatment and until the follow-up contact
Measured: up to 52 days
Safety and tolerability of repeat doses assessed by number of subjects with AEs
AEs will be collected from the start of study treatment and until the follow-up contact
Measured: up to 24 days
Secondary outcomes (10)
Single ascending doses plasma GSK2269557 PK assessed by AUC (0-t) and AUC (0-infinity)
To evaluate the single ascending doses PK, area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC[0-t]) and AUC from zero to infinity (AUC[0-infinity]) following single ascending doses will be assessed
Measured: 2 days of each treatment period in part A. Blood samples (2 mililiter [mL]) for plasma PK parameters will be collected on Day 1(pre-dose, 0.083, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 hrs post dose) and on Day 2 (24 hrs post dose).
Repeat doses plasma GSK2269557 PK assessed by AUC (0-t) and AUC (0-infinity)
To evaluate the repeat doses PK, (AUC[0-t]) and (AUC[0-infinity]) following repeated doses will be assessed
Measured: 15 days of part B. Blood samples (2 mL) for plasma PK parameters will be collected on Day 1 through Day 13 (pre-dose and 0.083 hrs post dose), on Day 14 (pre-dose, 0.083, 0.5, 0.75, 1, 2, 3, 4, 6, 8, and 12 hrs post dose), and on Day 15 (24 hrs post dose
Single ascending doses plasma GSK2269557 PK assessed by Cmax and Ctau
To evaluate the single ascending doses PK, maximum observed concentration (Cmax) and pre-dose (trough) concentration at the end of the dosing interval (Ctau) following single ascending doses will be assessed.
Measured: 2 days of each treatment period in part A. Blood samples (2 mL) for plasma PK parameters will be collected on Day 1(pre-dose, 0.083, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 hrs post dose) and on Day 2 (24 hrs post dose).
Repeat doses plasma GSK2269557 PK assessed by Cmax and Ctau
To evaluate the repeat doses PK, Cmax and Ctau following repeated doses will be assessed
Measured: 15 days of part B. Blood samples (2 mL) for plasma PK parameters will be collected on Day 1 through Day 13 (pre-dose and 0.083 hrs post dose), on Day 14 (pre-dose, 0.083, 0.5, 0.75, 1, 2, 3, 4, 6, 8, and 12 hrs post dose), and on Day 15 (24 hrs post dose
Single ascending doses plasma GSK2269557 PK assessed by Tmax and T1/2
To evaluate the single ascending doses PK, time to occurrence of Cmax and terminal phase half-life (T1/2) following single ascending doses will be assessed.
Measured: 2 days of each treatment period in part A. Blood samples (2 mL) for plasma PK parameters will be collected on Day 1(pre-dose, 0.083, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 hrs post dose) and on Day 2 (24 hrs post dose).
Repeat doses plasma GSK2269557 PK assessed by Tmax and T1/2
To evaluate the repeat doses PK, Tmax and T1/2 following repeated doses will be assessed.
Measured: 15 days of part B. Blood samples (2 mL) for plasma PK parameters will be collected on Day 1 through Day 13 (pre-dose and 0.083 hrs post dose), on Day 14 (pre-dose, 0.083, 0.5, 0.75, 1, 2, 3, 4, 6, 8, and 12 hrs post dose), and on Day 15 (24 hrs post dose
Steady state concentration assessed by BAL concentrations of GSK2269557 and derived ELF and cell pellet deposition after repeat doses
To investigate the steady-state trough concentration of GSK2269557 in lung after repeat doses, bronchial alveolar lavage (BAL) samples collected during bronchoscopy and derived epithelial lining fluid (ELF) and BAL cell pellet will be analyzed.
Measured: Day 15 of Part B
BAL and plasma concentrations of urea
To investigate the steady-state trough concentration of GSK2269557 after repeat doses.
Measured: Day 15 of Part B
Single ascending doses PD effect of GSK2269557 assessed by PIP3 in sputum cells
Sputum samples will be collected to evaluate single ascending doses pharmacodynamic (PD) effect of GSK2269557 on biomarker Phosphatidylinositol (3,4,5)-trisphosphate (PIP3) peak area as a proportion of (PIP3 peak area + PIP2 peak area) in sputum cells
Measured: Up to 52 days
Repeat doses PD effect of GSK2269557 assessed by PIP3 in sputum cells
Sputum samples will be collected to evaluate repeat doses PD effect of GSK2269557 on biomarker PIP3 peak area as a proportion of (PIP3 peak area + PIP2 peak area) in sputum cells
Measured: Up to 14 days (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study start9 Jan 2013
- Primary completion21 Oct 2013
- Study completion21 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762878
- Sponsor's protocol ID
- 116617
- Status last verified
- Jul 2017
- First submitted
- 4 Jan 2013
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Double-Blind, Placebo Controlled Two Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of GSK2269557 as a Dry Powder in Healthy Subjects Who Smoke Cigarettes
- ClinicalTrials.gov ID
- NCT01762878
- Acronym / sponsor ID
- 116617
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- pharmacodynamics, pharmacokinetics, healthy volunteers, Pi3K-delta, GSK2269557, safety, dry powder inhaler
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2013 (actual)
- Primary completion
- 21 Oct 2013 (actual)
- Study completion
- 21 Oct 2013 (actual)
- First posted
- 8 Jan 2013 (estimated)
- 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.
GSK2269557 is potent and highly selective inhaled phosphoinositides 3-kinases -delta (PI3K-delta) inhibitor being developed as an anti-inflammatory agent for the treatment of inflammatory airway diseases. GSK2269557 has already been administered as a nebulized solution in single and repeat doses to humans and has been well tolerated across the range of doses used. The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and repeat inhaled doses of GSK2269557 as a dry powder. This study is the first administration of dry powder GSK2269557 in humans.
Part A will consist of four treatment periods separated by at least 14 days wash out periods. In each treatment period there will be 12 subjects receiving GSK2269557 and 4 subjects receiving placebo. The doses of GSK2269557 planned for Part A are 100 micrograms (mcg), 500 mcg and 3000 mcg. Blinded safety and available pharmacokinetic (PK) data will be reviewed before each dose escalation. Part B will be a parallel group design conducted in a separate group of subjects from Part A. Nine subjects will receive repeat doses of GSK2269557 and 3 subjects will receive repeat doses of placebo for 14 days. The total daily dose will be the same as the dose that was well tolerated in Part A. The study duration, including screening and follow-up, is not expected to exceed 82 days for subjects in part A and 55 days for subjects in part B of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GSK2269557 100 mcg arm | Experimental | Drug: GSK2269557Each subject will receive 4 treatments in 4 treatment periods in Part A of the study. Subjects in this arm will be randomized to receive GSK2269557 100 mcg in one of the 4 treatment periods. |
| GSK2269557 500 mcg arm | Experimental | Drug: GSK2269557Each subject will undergo 4 treatments in 4 treatment periods in Part A of the study. Subjects in this arm will be randomized to receive GSK2269557 500 mcg in one of the 4 treatment periods |
| GSK2269557 3000 mcg arm | Experimental | Drug: GSK2269557Each subject will undergo 4 treatments in 4 treatment periods in Part A of the study. Subjects in this arm will be randomized to receive GSK2269557 3000 mcg in one of the 4 treatment periods |
| Placebo arm | Placebo comparator | Drug: PlaceboThe subjects will receive single dose of placebo in each treatment period of part A and repeat doses of placebo in Part B of the study. |
| Part B GSK2269557 arm | Experimental | Drug: GSK2269557The selection of total daily doses of GSK2269557 for Part B will anticipated to be the maximum well tolerated dose selected from Part A. The subjects will receive GSK2269557 in ratio of 3:1.with placebo. If the dose selected for Part B is not well tolerated on repeat dosing the dose may be reduced during Part B or given as divided doses. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects who are current daily cigarette smokers. Must have smoked regularly in the 12-month period preceding the screening visit and have a pack history of >= 5 pack years (number of pack years = number of cigarettes per day/20 x number of years smoked
- Normal spirometry (FEV1 >= 80% of predicted) at screening.
- Single QTcF < 450 milliseconds (msec); or QTcF< 480 msec in subjects with Right Bundle Branch Block
- Currently healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac testing. A subject with a clinical abnormality or laboratory parameters outside the reference range expected for them and the population being studied may be included only if the Investigator believes that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or outcomes
- Between 18 and 50 years of age inclusive, at the time of signing the informed consent
Key exclusion criteria (19 listed)
- Subjects who are unable to produce a total weight of at least 0.100 grams (g) of selected sputum at screening
- Subjects whose primary consumption of tobacco is via methods other than cigarettes (manufactured or self-rolled). Primary methods of tobacco consumption that are excluded include, but are not limited to pipes and cigars
- Urinary cotinine levels at screening < 30 nanograms (ng)/mL
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
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 |
|---|---|---|
| GSK2269557Dry powder for oral inhalation (100 and 500 mcg /blister) once daily using DIKUS device. The doses of GSK2269557 planned for Part A are: 100 mcg, 500 mcg and 3000 mcg | Drug | GSK2269557 100 mcg arm, GSK2269557 3000 mcg arm, GSK2269557 500 mcg arm, Part B GSK2269557 arm |
| PlaceboDry powder for oral inhalation once daily using DIKUS device | Drug | Placebo arm |
Primary outcome
Safety and tolerability of single ascending doses assessed by clinical monitoring of blood pressure
Time frame: up to 52 days
Blood pressure measurement will include systolic and diastolic blood pressure measured after resting in the supine position for 5 minutes
Safety and tolerability of repeat doses assessed by clinical monitoring of blood pressure
Time frame: up to 24 days
Pulse rate measurement should be done after resting in the supine position for 5 minutes
Safety and tolerability of single ascending doses assessed by pulse rate
Time frame: up to 52 days
Pulse rate measurement should be done after resting in the supine position for 5 minutes
Safety and tolerability of repeat doses assessed by pulse rate
Time frame: up to 24 days
Pulse rate measurement should be done after resting in the supine position for 5 minutes
Safety and tolerability of single ascending doses assessed by spirometry (FEV1)
Time frame: up to 52 days
Pulmonary function test measured from forced expiratory volume in 1 second (FEV1). Pulmonary function test will be repeated until three technically acceptable measurements have been made.
Safety and tolerability of repeat doses assessed by spirometry
Time frame: up to 24 days
Pulmonary function test measured from FEV1. Pulmonary function test will be repeated until three technically acceptable measurements have been made.
Safety and tolerability of single ascending doses assessed by Electrocardiogram (ECG)
Time frame: up to 52 days
12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT duration corrected for heart rate by Bazett's formula (QTcB)/ QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. ECGs will be measured after resting in supine position for 5 minutes
Safety and tolerability of repeat doses assessed by ECG
Time frame: up to 24 days
12-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcB/QTcF intervals. ECGs will be measured after resting in supine position for 5 minutes
Safety and tolerability of single ascending doses assessed by clinical laboratory test
Time frame: up to 52 days
Clinical laboratory test includes hematology, clinical chemistry, urinalysis and additional parameters
Safety and tolerability of repeat doses assessed by clinical laboratory test
Time frame: up to 24 days
Clinical laboratory test includes hematology, clinical chemistry, urinalysis and additional parameters
Safety and tolerability of single ascending doses assessed by number of subjects with adverse events (AEs)
Time frame: up to 52 days
AEs will be collected from the start of study treatment and until the follow-up contact
Safety and tolerability of repeat doses assessed by number of subjects with AEs
Time frame: up to 24 days
AEs will be collected from the start of study treatment and until the follow-up contact
10 secondary outcomes
Single ascending doses plasma GSK2269557 PK assessed by AUC (0-t) and AUC (0-infinity)
Time frame: 2 days of each treatment period in part A. Blood samples (2 mililiter [mL]) for plasma PK parameters will be collected on Day 1(pre-dose, 0.083, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 hrs post dose) and on Day 2 (24 hrs post dose).
Repeat doses plasma GSK2269557 PK assessed by AUC (0-t) and AUC (0-infinity)
Time frame: 15 days of part B. Blood samples (2 mL) for plasma PK parameters will be collected on Day 1 through Day 13 (pre-dose and 0.083 hrs post dose), on Day 14 (pre-dose, 0.083, 0.5, 0.75, 1, 2, 3, 4, 6, 8, and 12 hrs post dose), and on Day 15 (24 hrs post dose
Single ascending doses plasma GSK2269557 PK assessed by Cmax and Ctau
Time frame: 2 days of each treatment period in part A. Blood samples (2 mL) for plasma PK parameters will be collected on Day 1(pre-dose, 0.083, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 hrs post dose) and on Day 2 (24 hrs post dose).
Repeat doses plasma GSK2269557 PK assessed by Cmax and Ctau
Time frame: 15 days of part B. Blood samples (2 mL) for plasma PK parameters will be collected on Day 1 through Day 13 (pre-dose and 0.083 hrs post dose), on Day 14 (pre-dose, 0.083, 0.5, 0.75, 1, 2, 3, 4, 6, 8, and 12 hrs post dose), and on Day 15 (24 hrs post dose
Single ascending doses plasma GSK2269557 PK assessed by Tmax and T1/2
Time frame: 2 days of each treatment period in part A. Blood samples (2 mL) for plasma PK parameters will be collected on Day 1(pre-dose, 0.083, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 hrs post dose) and on Day 2 (24 hrs post dose).
Repeat doses plasma GSK2269557 PK assessed by Tmax and T1/2
Time frame: 15 days of part B. Blood samples (2 mL) for plasma PK parameters will be collected on Day 1 through Day 13 (pre-dose and 0.083 hrs post dose), on Day 14 (pre-dose, 0.083, 0.5, 0.75, 1, 2, 3, 4, 6, 8, and 12 hrs post dose), and on Day 15 (24 hrs post dose
Steady state concentration assessed by BAL concentrations of GSK2269557 and derived ELF and cell pellet deposition after repeat doses
Time frame: Day 15 of Part B
BAL and plasma concentrations of urea
Time frame: Day 15 of Part B
Single ascending doses PD effect of GSK2269557 assessed by PIP3 in sputum cells
Time frame: Up to 52 days
Repeat doses PD effect of GSK2269557 assessed by PIP3 in sputum cells
Time frame: Up to 14 days (Part B)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Results for study 116617 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 GSK2269557 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 9 inclusion and 19 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 13 Jul 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of single ascending doses assessed by clinical monitoring of blood pressure (time frame: up to 52 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2017.