A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants
Purpose
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.
Condition
- HIV Infections
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- Double-blind.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A: VH4770359 SAD group |
Healthy participants will receive a single dose of VH4770359 on Day 1. Up to 7 cohorts will receive single ascending doses (SAD). |
|
|
Placebo Comparator Part A: Placebo SAD group |
Healthy participants will receive a single dose of Placebo on Day 1. |
|
|
Experimental Part B: VH4770359 MAD group |
Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Up to 4 cohorts will receive multiple ascending doses (MAD). |
|
|
Placebo Comparator Part B: Placebo MAD group |
Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. |
|
|
Experimental Part B: VH4770359 MAD Drug-Drug Interaction (DDI) group |
Healthy participants will receive 14 daily repeat doses of VH4770359 from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14. |
|
|
Placebo Comparator Part B: Placebo MAD DDI group |
Healthy participants will receive 14 daily repeat doses of Placebo from Day 1 to Day 14. Participants will also receive 2 mg Midazolam on Days -1, Day 1 and Day 14. |
|
Recruiting Locations
GSK Investigational Site
Baltimore, Maryland 21225
Baltimore, Maryland 21225
More Details
- Status
- Recruiting
- Sponsor
- ViiV Healthcare