A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants
Status:
Completed
Trial end date:
2020-03-24
Target enrollment:
Participant gender:
Summary
This is an open-label, 2 part, single-dose and crossover study conducted to assess the
relative bioavailability of a tablet compared to a capsule of GSK3640254 and to assess the
effect of food on the GSK3640254 tablet in healthy participants. This study will also
evaluate the effect of food (fasted, moderate fat meal, and high fat meal) on the
pharmacokinetics of the GSK3640254 mesylate tablet formulation. In Part 1, participants will
be randomly assigned to 1 of 2 treatment sequences (AB or BA) in two sequential treatment
periods; and in Part 2, participants will be randomly assigned to 1 of 3 treatment sequences
(CDE, DEC, or ECD) in three sequential treatment periods. Participants will be randomized to
receive a single dose of GSK3640254 200 milligram (mg) capsules under moderate fat conditions
and GSK3640254 200 mg tablets under moderate fat, fasted and high fat conditions in each
treatment period. Approximately 30 participants will be enrolled.