At a glance
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A Double-Blind (Sponsor Unblinded), Randomized, Placebo-Controlled, Single and Repeated Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK3739937 in Healthy Participants
In Brief
A Phase 1 clinical trial evaluating GSK3739937 (PIB), Placebo, and 1 other intervention for HIV Infections. Completed, enrolled 91 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
GSK3739937 will be administered as oral suspension.
Placebo will be given orally during each dosing day.
GSK3739937 Tablet will be administered via oral route.