A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
ConditionHIV Infections
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorViiV Healthcare
About this trial
VH4770359 (also known as GSK4770359) is an antiretroviral compound. This first-in-human study aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered VH4770359 in healthy participants. The findings from this study will support the design of future clinical studies of VH4770359 in people living with HIV.
Eligibility criteria
Qualifiers
18 to 55 years old
BMI 18.5-37.0 kg/m2
Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant/breastfeeding and be of non-childbearing potential.
Disqualifiers
Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct.
Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy.
A positive test(s) for Hepatitis B surface antigen (HBsAg) and/or anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV).
A history of or ongoing high-risk behaviors for HIV acquisition.
Trial design
Treatments tested in this trial
- VH4770359
- Placebo
- Midazolam
Treatment groups
214 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov