GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers

Status Completed

Clinical Trial Summary

Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat throughout the world and development of medicines with new mechanism of action have an important role to play. GSK3640254 is a maturation inhibitor (MI) and can be effective in HIV-1 treatment. This randomized, 2-part, single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of in healthy subjects for GSK3640254. The information collected in this study will help in further clinical development of GSK3640254, including a Phase IIA Proof of Concept (PoC) study in HIV-infected subjects. Approximately 16 healthy subjects will be randomized to receive single oral dose of GSK3640254 and placebo in Part 1 and approximately 56 healthy subjects will be randomized to receive repeat oral dose of GSK3640254 or placebo in Part 2. All doses will be given immediately after a moderate fat meal. Maximum duration of study participation will be approximately 12 weeks.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Infection, Human Immunodeficiency Virus

Clinical Trial Details

NCT number	NCT03231943
Study type	Interventional
Source	ViiV Healthcare
Contact
Status	Completed
Phase	Phase 1
Start date	September 19, 2017
Completion date	September 9, 2018

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