NCT05631704

A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity

A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single and Multiple Ascending Dose First-Time-in-Human Study to Investigate the Safety, Tolerability, and Pharmacokinetics of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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	Placebo will be administered.

Timeline

• Start date: 2022-12-02
• Primary completion: 2023-07-27
• Completion: 2023-07-27
• First posted: 2022-11-30
• Last updated: 2025-12-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study