A Phase 1 interventional study of GSK2256294 in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
This study will investigate the safety and pharmacokinetics (PK) of a single dose of GSK2256294 in healthy young and elderly subjects to explore the effects of food, gender and age on drug exposure. The biliary metabolites in healthy young males will be investigated using the Entero-test after a single oral dose of GSK2256294. This study will be conducted in two cohorts (Cohort 1 and Cohort 2). Cohort 1 is open label in order to characterise the PK profile of GSK2256294 in healthy young males and also to investigate the biliary metabolites of GSK2256294. Cohort 2 uses a crossover design to allow comparison of the PK parameters of GSK2256294 between in the fed and fasted state within subject and also to compare the PK parameters of GSK2256294 between male and female subjects. A washout period of a minimum of 2 weeks has been chosen to allow and adequate washout of GSK2256294.
4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 28 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
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Cohort 1 only: BP \<=130/80.
Exclusion Criteria:
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Cohort 1 will enrol 8 healthy male volunteers, who will receive a single 10 mg dose of GSK225694 in the fasted state.
Drug: GSK2256294
Cohort 2 will enrol 20 healthy elderly male and female volunteers (10 males and 10 females), who will receive a single 10 mg dose of GSK225694 in the fasted or fed state according to the randomization schedule.
Drug: GSK2256294
GSK2256294 is a 5 mg capsule administered orally as a 10 mg dose in the fasted or fed state
Cohort 2: PK profiles of a single oral dose of GSK2256294
PK parameters including area under the concentration-time curve (AUC) and maximum blood concentrations (Cmax), half life (T1/2), time to Cmax (Tmax) following a single oral dose of GSK2256294 administered under fed and fasted conditions in healthy elderly male and female subjects will be estimated
Time frame: Pre-dose, 15 minutes (min), 30 min, 1 hour (h), 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1) and 24 h (Day 2), 48 h (Day 3) and 72 h (Day 4)
Cohort 2: Electrocardiogram (ECG) as a measure of safety and tolerability
Twelve-lead ECGs will be obtained as a measure of safety and tolerability
Time frame: Screening, Pre-dose, 30 min, 2 h, 4 h, 6 h and at follow-up
Cohort 2: Adverse events (AEs ) as a measure of safety and tolerability
Time frame: From the start of study treatment and until approximately 2 weeks after the final dose
Cohort 2: Vital signs as a measure of safety and tolerability
Vital sign measurements will include systolic and diastolic blood pressure (BP) and pulse rate
Time frame: Screening, Pre-dose, 30 min, 2 h, 4 h, 6 h and at follow-up
Cohort 2: Laboratory assessments as a measure of safety and tolerability
Clinical laboratory assessments will include haematology, clinical chemistry, urinalysis and other screening tests
Time frame: Screening and follow-up. In addition, clinical chemistry will also be done at 12 h (Day 1) and 24 h (Day 2)
Cohort 1: Biliary metabolite profile of GSK2256294
Bile will be collected for metabolic analysis of GSK2256294 + metabolites via the use of the Entero-Test capsule in healthy male younger subjects
Time frame: Until 7 hours post-dose on Day 1
Cohort 1: AEs as a measure of safety and tolerability
Time frame: From the start of study treatment and until approximately 2 weeks after the final dose
Cohort 1: ECG as a measure of safety and tolerability
Twelve-lead ECGs will be obtained to assess safety and tolerability
Time frame: Screening, Pre-dose, 30 min, 2 h, 4 h, 6 h and at follow-up
Cohort 1: Vital signs as a measure of safety and tolerability
Vital sign measurements will include systolic and diastolic BP and pulse rate
Time frame: Screening, Pre-dose, 30 min, 2 h, 4 h, 6 h and at follow-up
Cohort 1: Laboratory assessments as a measure of safety and tolerability
Clinical laboratory assessments will include haematology, clinical chemistry, urinalysis and other screening tests
Time frame: Screening and follow-up
Cohort 1 and Cohort 2: AUC, Cmax, t1/2,and Tmax of GSK2256294
To compare the pharmacokinetic profiles of single oral doses of GSK2256294 in healthy elderly and healthy younger subjects, and between healthy elderly male and female subjects
Time frame: Cohort 1: Pre-dose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 7 h, 12 h and 24 h, 48 h, and 72 h; Cohort 2: Pre-dose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h and 24 h, 48 h and 72 h
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gsk-2256294
Pulmonary Disease, Chronic Obstructive →