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

NCT06533280 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-04-22

No results posted yet for this study

Summary

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

Conditions

  • HIV Infections

Interventions

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.

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-02
Primary Completion
2024-08-14
Completion
2024-08-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06533280 on ClinicalTrials.gov