A Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK2556286 in Healthy Adult Participants
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, placebo-controlled, first time in human (FTIH) study to
evaluate the safety, tolerability and pharmacokinetics (PK) of single and repeat ascending
doses of GSK2556286 following oral administration in healthy adult participants. A food
effect (FE) cohort will investigate the influence of food on the PK of GSK2556286. The study
will be conducted in two parts. Part A will be a single ascending dose (SAD), sequential,
parallel cohort design including up to 8 cohorts (Cohort 1A to cohort 8A) and Part B will be
a multiple ascending dose (MAD), sequential, parallel dose cohort design including up to 4
cohorts (Cohort 1B to cohort 4B). In each cohort of Part A and Part B, participants will be
randomized to receive single and repeated oral doses, respectively, of either GSK2556286 or
matching placebo, administered in a 3:1 ratio according to the randomization schedule in a
blinded manner. In Part A, Cohort 1A till cohort 6A will be dosed under fasted conditions and
Cohort 7A and cohort 8A will be dosed under fed conditions. Cohort 7A will investigate the
effect of food administration (high fat meal) on safety, tolerability and PK after a single
dose of GSK2556286. Based on emerging data, a second food effect cohort (Cohort 8A) may also
be included using a higher dose of GSK2556286. Progression from Part A to Part B will be
based on an acceptable safety, tolerability and PK profile in Part A. In Part B, participants
in each cohort will receive a daily oral dose of GSK2556286 over a period of up to 14 days.
Part B may include drug administration after either fed or fasted conditions, dependent on
the results from Part A. Sentinel dosing will be used in each cohort in Part A and Part B.
Participants can only take part in one dose cohort in either Part A or B of the study.