A Safety and Pharmacokinetic (PK) Study of GSK2982772 in Healthy Subjects
Status:
Completed
Trial end date:
2018-10-15
Target enrollment:
Participant gender:
Summary
This study is designed to evaluate the safety, tolerability and PK of GSK2982772, in repeat
oral doses in healthy subjects. This study is being conducted to support administration of
higher dose levels of GSK2982772 than initially studied in the First Time in Human (FTiH)
study. This study will also assess the impact of food during the repeat doses of GSK2982772.
This will be a two part study; Part A and Part B. Part A (cohort 1) - single ascending dose,
randomized, placebo-controlled, 3-way crossover. Part B (cohorts 2, 3, 4 and 5) - repeat
dose, randomized, placebo-controlled, sequential-group. Subjects will be randomized in 3:1
ratio to receive GSK2982772 or placebo in crossover manner on Day 1 of each of the three
periods in Part A. Subjects will be randomized in 3:1 ratio to receive GSK2982772 or placebo
in sequential groups for 14 days in cohort 2 of Part B and in 9:5 ratio to receive GSK2982772
or placebo in sequential groups for 14 days in cohorts 3, 4 and 5 of Part B. Approximately 66
subjects will be included in this study. The study duration, including screening and
follow-up, will not be expected to exceed 13 weeks for Part A and 8 weeks for Part B.