Safety, Tolerability and Pharmacokinetics (PK) Investigation of GSK3494245 in Healthy Participants
Status:
Suspended
Trial end date:
2022-10-18
Target enrollment:
Participant gender:
Summary
This is a Phase 1, double-blind, randomized, placebo-controlled, first time in human (FTIH)
study to assess the safety, tolerability and PK of a single dose of GSK3494245. The study
will consist of 3 cohorts, conducted in a sequential manner. Cohorts 1 and 2 will consist of
a single ascending dose (SAD), crossover design where each participant will receive a maximum
of 3 ascending oral doses of GSK3494245 and 1 placebo dose under fasted conditions. At each
dose level, GSK3494245 and placebo will be administered in a 3:1 ratio, within each period,
according to the randomization schedule in a blinded manner. Cohort 3 will comprise of a
2-way crossover which includes 1 dosing regimen under fasted then fed conditions and 1
regimen under fed then fasted conditions in a 1:1 ratio. The fed conditions will investigate
the effect of safety, tolerability and PK of a single dose of GSK3494245 following food
administration.