Not Yet RecruitingPhase 1

Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184

9 participantsStarted 2026-06-15

Plain-language summary

The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.

Who can participate

Age range

18 Years – 55 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

. Willing and able to sign the Informed Consent Form (ICF).
. Sex at birth: male or female; female participants must be of non-childbearing potential, or postmenopausal.
. Age: 18 to 55 years, inclusive, at screening.
. BMI: 18.0 to 32.0 kg/m\^2, inclusive, at screening.
. Female participants of non-childbearing potential must have unequivocal documentation that they are not of childbearing potential Postmenopausal female participants must have a serum follicle-stimulating hormone (FSH) concentration \>33.4 milli-international units per milliliter (mIU/mL) at screening to confirm menopause.
. Male participants, if not surgically sterilized and who have a female partner of childbearing potential, must agree to use a condom during any sexual intercourse until the completion of the follow-up visit.
. Male participants must agree not to donate sperm from admission on Day -1 until the completion of the follow-up visit.
. All prescribed medication must have been stopped at least 30 days and \>5 half-lives prior to admission to the clinical site on Day -1.

Exclusion criteria

. Employee of ICON, the Sponsor, GSK or associated vendors.

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.

1This trial uses a radioactive form of the drug called [14C]VH4524184 to track how the body absorbs and eliminates it — what does that mean for my radiation exposure, and is that level considered safe?
2Since this is a Phase 1 trial that hasn't started recruiting yet, how much is already known about VH4524184's safety in humans, and how would participating compare to staying on or starting a standard proven HIV treatment?
3The trial involves collecting urine, feces, and possibly vomit samples across two study periods — can you help me understand how demanding the schedule and sample collection process would actually be day-to-day, and whether that's realistic for my situation?
4Because this study is primarily measuring how the drug moves through and out of the body rather than whether it controls HIV, would joining this trial mean my HIV treatment needs could be left unaddressed during the study period?
5Given that this trial isn't recruiting yet, what is your best estimate of when it might open, and in the meantime, what treatment options would you recommend we pursue for my HIV care?

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

Absolute bioavailability (F oral) of VH4524184 (Period 1)

Timeframe: Day 1 up to Day 14

Amount of total radioactivity (TRA) excreted in urine (Ae urine) (Period 1)

Timeframe: Day 1 up to Day 14

Amount of TRA excreted in urine (Ae urine) (Period 2)

Timeframe: Day 15 up to Day 43

Amount of TRA excreted in feces (Ae feces) (Period 1)

Timeframe: Day 1 up to Day 14

Amount of TRA excreted in feces (Ae feces) (Period 2)

Timeframe: Day 15 up to Day 43

Amount of TRA excreted in vomitus (Ae vomit) (Period 1)

Timeframe: At Day 1

Amount of TRA excreted in vomitus (Ae vomit) (Period 2)

Timeframe: At Day 15

Trial details

NCT IDNCT07636928

SponsorViiV Healthcare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-20

Contact for this trial

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

View on ClinicalTrials.gov More HIV Infections trials

Who can participate

Age range

18 Years – 55 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

. Willing and able to sign the Informed Consent Form (ICF).
. Sex at birth: male or female; female participants must be of non-childbearing potential, or postmenopausal.
. Age: 18 to 55 years, inclusive, at screening.
. BMI: 18.0 to 32.0 kg/m\^2, inclusive, at screening.
. Female participants of non-childbearing potential must have unequivocal documentation that they are not of childbearing potential Postmenopausal female participants must have a serum follicle-stimulating hormone (FSH) concentration \>33.4 milli-international units per milliliter (mIU/mL) at screening to confirm menopause.
. Male participants, if not surgically sterilized and who have a female partner of childbearing potential, must agree to use a condom during any sexual intercourse until the completion of the follow-up visit.
. Male participants must agree not to donate sperm from admission on Day -1 until the completion of the follow-up visit.
. All prescribed medication must have been stopped at least 30 days and \>5 half-lives prior to admission to the clinical site on Day -1.

Exclusion criteria

. Employee of ICON, the Sponsor, GSK or associated vendors.

What they're measuring

Absolute bioavailability (F oral) of VH4524184 (Period 1)

Timeframe: Day 1 up to Day 14

Amount of total radioactivity (TRA) excreted in urine (Ae urine) (Period 1)

Timeframe: Day 1 up to Day 14

Amount of TRA excreted in urine (Ae urine) (Period 2)

Timeframe: Day 15 up to Day 43

Amount of TRA excreted in feces (Ae feces) (Period 1)

Timeframe: Day 1 up to Day 14

Amount of TRA excreted in feces (Ae feces) (Period 2)

Timeframe: Day 15 up to Day 43

Amount of TRA excreted in vomitus (Ae vomit) (Period 1)

Timeframe: At Day 1

Amount of TRA excreted in vomitus (Ae vomit) (Period 2)

Timeframe: At Day 15