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

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.

Timeline

Start

2020-07-31

Primary completion

2021-08-30

Completion

2021-08-30

Publications

• Background Benn PD, Zhang Y, Kahl L, Greene TJ, Bainbridge V, Fishman C, Wen B, Gartland M. A phase I, first-in-human study investigating the safety, tolerability, and pharmacokinetics of the maturation inhibitor GSK3739937. Pharmacol Res Perspect. 2023 Jun;11(3):e01093. doi: 10.1002/prp2.1093.

Drugs

Indications