NCT04493684

GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	GSK3739937 (PIB)	GSK3739937 will be administered as oral suspension.
DRUG	Placebo	Placebo will be given orally during each dosing day.
DRUG	GSK3739937 (Tablet)	GSK3739937 Tablet will be administered via oral route.

Timeline

• Start date: 2020-07-31
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2020-07-30
• Last updated: 2025-07-16
• Results posted: 2023-08-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study