A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2849466 in Healthy Male Subjects
Status:
Completed
Trial end date:
2013-05-03
Target enrollment:
Participant gender:
Summary
This study is the first administration of GSK2849466 in humans. This will be a single centre,
randomized, double-blind, placebo-controlled study, to investigate the safety, tolerability,
pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2849466, given as single and repeat
oral doses up to 14 days to healthy male subjects. Part A will be a randomized placebo
controlled and 4-way crossover study. It will include two cohorts of 8 subjects each. In each
cohort there will be 4 study periods each approximately of 1 week including 6 days of
washout. Each subject will receive a total of 3 active doses as ascending single oral dose of
GSK2849466 and 1 placebo dose during the course of their participation in the study. The
first ("bridging dose") dose provided to subjects in Cohort 2 will be the same as the last
dose provided to subjects in Cohort 1. The single doses of GSK2849466 planned in Part A of
this study are: 0.01, 0.03, 0.1, and 0.3 milligram (mg) in Cohort 1 and 0.3, 1, 3, and 10 mg
in Cohort 2. In cohorts 1 and 2 all available safety, tolerability, and PK data will be
reviewed prior to each dose escalation. The dosing schedule in Part A may be adjusted to
expand a cohort or to add an additional cohort(s) in order to further evaluate additional
doses or repeat evaluation of a dose level already studied. Part B will be a randomized
placebo controlled, parallel group study. It will include three cohorts of 12 subjects each.
Each subject will receive repeat doses of GSK2849466 over 14 days. The doses chosen for Part
B will be based on the safety, tolerability, and PK data from Part A. Subjects in Cohort 4
(and/or an another cohort [s] as determined based on Part A PK data) will be dosed in the
fasted state on Days 1 and 14 and in the fed state on Day 7 when subjects will receive a
standard meal 30 minutes prior to dosing. Part B will provide sufficient safety and
tolerability data to bridge to longer duration studies. The study duration, including
screening and follow-up, is not expected to exceed 70 days for subjects in the study.