Safety, Tolerability and Pharmacokinetics (PKs) Investigation of GSK3186899 in Healthy Subjects
Status:
Terminated
Trial end date:
2019-10-17
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the safety, tolerability and PK profile of single
and repeat ascending doses of GSK3186899 in healthy subjects. This is a Phase 1 first time in
human study, to investigate the effect of food on PK of GSK3186899. This study will consists
of two parts. Part A (dose escalation phase) will be a single ascending, sequential
cross-over design in cohorts 1, 2 and 3 of subjects. Cohort 1 and 2 will be 4-way cross-over
which includes 4 dosing regimens of GSK3186899 and placebo (3:1 ratio) under fasted
conditions. Cohort 3 will be 2-way cross-over which includes 2 treatment periods, 2 dosing
regimens in fasted and fed conditions. In Part B (repeat dose escalation phase) subjects will
be randomized to receive repeat doses of either GSK3186899 or placebo (3:1 ratio) in either
fed or fasted conditions. Part B will be conducted based on the review of all safety,
tolerability and PK data from Part A. The study duration includes screening, treatment
periods and follow-up.