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 range

18 Years – 60 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 60 Years

Sex

ALL

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