What this study is
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.
What's being tested
- VH4770359
Intervention · DRUG
Participants will receive the assigned dose formulation of VH4770359 orally.
- Placebo
Intervention · DRUG
Participants will receive placebo to match the VH4770359 dose formulation.
- Midazolam
Intervention · DRUG
Participants receive 2 mg Midazolam on Days -1, Day 1 and Day 14.
Study details
- Official title
- A Multi-part, Phase 1, First-Time-in-Human Study to Investigate Safety, Tolerability, and PK of VH4770359 in Healthy Participants
- Sponsor
- ViiV Healthcare
- Conditions
- HIV Infections
- Enrolling
- 214 people
- Starts
- 2026-05-14
- Est. completion
- 2027-05-05
- Design
- Triple-blind, randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 55 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
- Use of prohibited medications.
- Exclusionary allergies or sensitivities.
- Regular use of alcohol, drugs of abuse, tobacco, or nicotine products.
- Exclusionary prior or concurrent clinical study participation.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openGSK Investigational Site
Baltimore, Maryland, United States
- US GSK Clinical Trials Call Center · Contact877-379-3718GSKClinicalSupportHD@gsk.com
- EU GSK Clinical Trials Call Centre · Contact+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com
- Ronald Goldwater · Principal investigator
Recruiting
Study team
Sponsor
ViiV Healthcare
Study ID 300109
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.