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) | Biotech Hunter

Timeline

Start Date

August 2, 2024

Primary Completion Date

August 14, 2024

Study Completion Date

August 14, 2024

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.

Trial Locations (1)

GSK Investigational Site, Baltimore