NCT06533280

VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI)

A Multi-part Phase 1 Study Assessing the Safety, Tolerability, and PK of VH3739937 in Healthy Participants, by Conducting MAD and RBA Cohorts, With Optional Food Effect and Drug Interaction Cohorts

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will assess safety, tolerability and pharmacokinetic (PK) of VH3739937 in healthy participants.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Part A, C and D: VH3739937 500 mg	Oral administration of VH3739937 in moderate fat/moderate calorie conditions
DRUG	Part A: VH3739937 100 mg	Oral administration of VH3739937 in moderate fat/moderate calorie conditions.
DRUG	Part A and C: Placebo	Oral administration of Placebo in moderate fat/moderate calorie conditions
DRUG	Part B: Treatment A	VH3739937, 500 mg(single dose given as 5 x 100 mg tablets). administered under moderate fat/moderate calorie conditions (reference)
DRUG	Part B: Treatment B	VH3739937, 500 mg (single dose given as 500 mg tablet) administered under moderate fat/moderate calorie conditions (test)
DRUG	Part B: Treatment C	VH3739937, 500 mg single tablet administered under fasted conditions.
DRUG	Part B: Treatment D	VH3739937, 500 mg single tablet administered under low-fat/ low calorie conditions.
DRUG	Part B: Treatment E	VH3739937, 500 mg single tablet administered under high-fat/ high calorie conditions.
DRUG	Part D: Probe cocktail	Oral administration of probe cocktail (Midazolam, Digoxin, Total Dabigatran etexilate, Rosuvastatin) in moderate fat/moderate calorie conditions.

Timeline

• Start date: 2024-08-02
• Primary completion: 2024-08-14
• Completion: 2024-08-14
• First posted: 2024-08-01
• Last updated: 2025-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study