VH4770359: Participants will receive the assigned dose formulation of VH4770359 orally.
Placebo: Participants will receive placebo to match the VH4770359 dose formulation.
Midazolam: Participants receive 2 mg Midazolam on Days -1, Day 1 and Day 14.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. 18 to 55 years old
2. BMI 18.5-37.0 kg/m2
3. Male participants must adhere to contraception requirements or abstinence, and female participants must not be pregnant/breastfeeding and be of non-childbearing potential.
Exclusion Criteria:
1. Participants with significant medical history that could alter drug pharmacokinetics, pose a risk, or interfere with conduct.
2. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition, or exclusionary malignancy.
3. A positive test(s) for Hepatitis B surface antigen (HBsAg) and/or anti-HBc, hepatitis C antibodies, or human immunodeficiency virus (HIV).
4. A history of or ongoing high-risk behaviors for HIV acquisition.
5. Use of prohibited medications.
6. Exclusionary allergies or sensitivities.
7. Regular use of alcohol, drugs of abuse, tobacco, or nicotine products.
8. Exclusionary prior or concurrent clinical study participation.
Primary outcome measure(s)
Number of participants with Grade 3 and Grade 4 adverse events (AEs) — From Day 1 (first dose of study intervention) in each treatment period until the last on-site study visit (up to approximately 9 weeks) An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The AEs are graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria where grades are defined based on numeric criteria as follows Grade 3: severe symptoms; Grade 4: potentially life-threatening. A higher grade indicates greater severity.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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