GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers
GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers
NCT ID: NCT04493684 Phase: PHASE1 Status: COMPLETED Enrollment: 91 Completion: 2021-08-30
Conditions
HIV Infections
Interventions
GSK3739937 (PIB), Placebo, GSK3739937 (Tablet)
Summary
This study is a Phase 1, double-blind (sponsor-unblinded), randomized, placebo-controlled, single- and repeat-dose escalation study including a weekly oral dose (MAD) cohort and a relative bioavailability (RBA) and food effect (FE) cohort to investigate the safety, tolerability and PK of VH3739937 in healthy participants. This is a three part study. Part 1 and Part 2 is designed to gain information on the safety, tolerability, and pharmacokinetic (PK) properties of GSK3739937 when administered as powder-in-a-bottle (PiB). Part 3 will evaluate the RBA of the GSK3739937 PiB and GSK3739937 Tablet and the safety, tolerability and PK parameters of the tablet formulation when administered under fasting and fed conditions.
Primary Outcome
Part 1 - Number of Any Adverse Events (AEs) and Serious Adverse Events (SAEs)