CompletedPhase 1

A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults

United States126 participantsStarted 2025-07-07

Plain-language summary

The aim of the study is to gather information on how the drug behaves in healthy adults, how it is absorbed, and how it interacts when taken with other medicines.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male Participants: No restrictions for male participants
✓. A female participant (female sex assigned at birth) is eligible to participate if she is not pregnant, or breastfeeding and the following condition applies: She is a woman of nonchildbearing potential (WONCBP).

Exclusion criteria

✕. History or presence of clinical conditions affecting drug absorption, metabolism, or elimination.,
✕. Pre-existing clinically relevant, gastro-intestinal pathology
✕. Abnormal glucose metabolism requiring insulin or medications.
✕. Clinically significant Abnormal blood pressure.
✕. History of Lymphoma, leukemia, or any malignancy within the past 5 years (3 years for resected basal or squamous epithelial carcinomas of skin).
✕. Breast cancer within the past 10 years.
✕. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
✕. History of syncope, clinically significant palpitations, cardiac arrhythmias or cardiac disease or a family long QT syndrome.

What they're measuring

Part 1: Maximum plasma concentration (Cmax) for VH4524184

Timeframe: Up to Day 18

Part 1: Area under the concentration-time curve from 0 to tau (AUC0-t) for VH4524184

Timeframe: Up to day 18

Part 1: Area under the concentration-time curve from 0 to infinity (AUC0-inf) for VH4524184

Timeframe: Up to day 18

Part 2: Cmax for VH4524184

Timeframe: At Day 1, Day 14, Day 19 and Day 22

Part 2: AUC0-t of VH4524184

Timeframe: At Day 1, Day 14, Day 19 and Day 22

Part 2: AUC0-inf of VH4524184

Timeframe: At Day 1, Day 14, Day 19 and Day 22

Part 2: Cmax for metformin

Timeframe: At Day 1 and Day 15

Part 2: AUC0-t for metformin

Timeframe: At Day 1 and Day 15

Trial details

NCT IDNCT07066722

SponsorViiV Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-17

View on ClinicalTrials.gov More HIV Infections trials

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male Participants: No restrictions for male participants
✓. A female participant (female sex assigned at birth) is eligible to participate if she is not pregnant, or breastfeeding and the following condition applies: She is a woman of nonchildbearing potential (WONCBP).

Exclusion criteria

✕. History or presence of clinical conditions affecting drug absorption, metabolism, or elimination.,
✕. Pre-existing clinically relevant, gastro-intestinal pathology
✕. Abnormal glucose metabolism requiring insulin or medications.
✕. Clinically significant Abnormal blood pressure.
✕. History of Lymphoma, leukemia, or any malignancy within the past 5 years (3 years for resected basal or squamous epithelial carcinomas of skin).
✕. Breast cancer within the past 10 years.
✕. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
✕. History of syncope, clinically significant palpitations, cardiac arrhythmias or cardiac disease or a family long QT syndrome.

What they're measuring

Part 1: Maximum plasma concentration (Cmax) for VH4524184

Timeframe: Up to Day 18

Part 1: Area under the concentration-time curve from 0 to tau (AUC0-t) for VH4524184

Timeframe: Up to day 18

Part 1: Area under the concentration-time curve from 0 to infinity (AUC0-inf) for VH4524184

Timeframe: Up to day 18

Part 2: Cmax for VH4524184

Timeframe: At Day 1, Day 14, Day 19 and Day 22

Part 2: AUC0-t of VH4524184

Timeframe: At Day 1, Day 14, Day 19 and Day 22

Part 2: AUC0-inf of VH4524184

Timeframe: At Day 1, Day 14, Day 19 and Day 22

Part 2: Cmax for metformin

Timeframe: At Day 1 and Day 15

Part 2: AUC0-t for metformin

Timeframe: At Day 1 and Day 15