A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity
NCT05631704 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2025-12-29
Summary
This study is designed to investigate the safety, tolerability and PK of VH4524184 (GSK4524184) and the potential of VH4524184 to inhibit or induce CYP3A activity in healthy participants.
Conditions
- HIV Infections
Interventions
- DRUG
-
VH4524184
VH4524184 will be administered.
- DRUG
-
Midazolam
Midazolam will be administered in the highest dose cohort in Part 2 (Cohorts 8 or 9).
- DRUG
-
Placebo will be administered.
Sponsors & Collaborators
-
ViiV Healthcare
lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · ViiV Healthcare
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-12-02
- Primary Completion
- 2023-07-27
- Completion
- 2023-07-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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