HIV InfectionsPhase 1NCT07636928
Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184
A Phase 1 study testing VH4524184, [14C]VH4524184 microdose and [14C]VH4524184 in people with HIV Infections, run by ViiV Healthcare at 1 site in Netherlands.
Trial summary
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- VH4524184, [14C]VH4524184 microdose and [14C]VH4524184
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Jun 2026to 20 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
- All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications must have been stopped at least 14 days prior to admission to the clinical site on Day -1. An exception is made for paracetamol that is allowed up to admission to the clinical site on Day -1.
- Ability and willingness to abstain from alcohol from 48 hours prior to screening and admission to the clinical site on Day -1 until the last PK sample.
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, black tea, green tea, white tea, cola, chocolate, energy drinks), and grapefruit (juice) from 48 hours prior to admission to the clinical site.
- Good physical and mental health based on medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the Investigator.
Who cannot join
- Employee of ICON, the Sponsor, GSK or associated vendors.
- History of relevant drug and/or food allergies.
- History of drug hypersensitivity, delayed-type hypersensitivity, or severe hypersensitivity reactions, as well as history of sensitivity to the study drug.
- Using tobacco/nicotine products within 60 days prior to the first study drug administration.
- History of alcohol abuse or drug addiction within 5 years prior to screening.
- Positive drug and/or alcohol screen at screening or admission to the clinical site.
Show all 17Show fewer
- Average intake of more than 24 units of alcohol per week.
- Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies at screening.
- Participation in a drug study with a small molecule drug within 30 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in a clinical study with a biological within 90 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to the first study drug administration in the current study.
- Donation or loss of more than 450 mL of blood within 60 days prior to the first study drug administration. Donation or loss of more than 1.5 L of blood (for male participants)/more than 1.0 L of blood (for female participants) in the 10 months prior to the first study drug administration in the current study.
- Significant and/or acute illness within 14 days prior to the first study drug administration that may impact safety assessments, in the opinion of the Investigator.
- Any significant current/ongoing known or suspected pre-existing psychiatric condition, including depression, anxiety, and/or insomnia/sleep disturbances and/or suicidal ideation, in the opinion of the Investigator.
- Unsuitable veins for infusion or blood sampling.
- Participation in a study with a 14C dose of ≥0.1 megabecquerel (MBq) in the period of 1 year prior to screening.
- Irregular defecation pattern.
- Pre-existing clinically relevant, in the opinion of the Investigator in discussion with the Sponsor medical monitor, gastro-intestinal pathology or diagnosis, eg, irritable bowel syndrome, inflammatory bowel disease, and/or significant baseline signs and symptoms.
- History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drugs, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits, in the opinion of the Investigator. The Investigator may contact the Sponsor medical monitor to discuss the inclusion of participants who have a history of specific conditions that are not expected to interfere with their participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Groningen, 9728 NZ
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 1, Open-Label, Single Dose Study to Assess the Absolute Bioavailability, Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]VH4524184 in Healthy Participants
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.
- Conditions
- HIV Infections
- Being tested
- VH4524184, [14C]VH4524184 microdose, [14C]VH4524184
- Keywords
- VH4524184, Human immunodeficiency virus (HIV)
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VH4524184Drug
One dose of VH4524184 is administered to participants at time zero on Day 1 (Period 1).
[14C]VH4524184 microdoseDrug
A radiolabelled microdose of [14C]VH4524184 is administered 2.5 hours after VH4524184 dose administration on Day 1 (Period1).
[14C]VH4524184Drug
One dose of radiolabelled [14C]VH4524184 is administered to participants at Day 15 (Period 2).
| Study group | Role | What they receive |
|---|---|---|
| VH4524184 Group | Experimental | Participants will receive a dose of VH4524184 under fasting conditions, followed by a microdose of radiolabelled [14C]VH4524184 administered 2.5 hours after first dose administration at time zero on Day 1 (Period1). After a 14 days wash-out period participants will receive a radiolabelled dose of [14C]VH4524184 on Day 15 under fasting conditions. Receives: Drug: VH4524184; Drug: [14C]VH4524184 microdose; Drug: [14C]VH4524184 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability (F oral) of VH4524184 (Period 1)
Measured: Day 1 up to Day 14
Amount of total radioactivity (TRA) excreted in urine (Ae urine) (Period 1)
Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Measured: Day 1 up to Day 14
Amount of TRA excreted in urine (Ae urine) (Period 2)
Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Measured: Day 15 up to Day 43
Amount of TRA excreted in feces (Ae feces) (Period 1)
Feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Measured: Day 1 up to Day 14
Amount of TRA excreted in feces (Ae feces) (Period 2)
Feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Measured: Day 15 up to Day 43
Amount of TRA excreted in vomitus (Ae vomit) (Period 1)
Measured: At Day 1
Amount of TRA excreted in vomitus (Ae vomit) (Period 2)
Measured: At Day 15
Total amount of TRA excreted (Ae total) (Period 1)
The Ae of TRA measured in urine, feces and vomitus (if applicable on Day 1 only). Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Measured: From Day 1 up to Day 14
Total amount of TRA excreted (Ae total) (Period 2)
The Ae of TRA measured in urine, feces and vomitus (if applicable on Day 15 only). Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Measured: Day 15 up to Day 43
Fraction of TRA excreted in urine (fe urine) (Period 1)
Urine is collected until the amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Measured: Day 1 up to Day 14
Fraction of TRA excreted in urine (fe urine) (Period 2)
Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Measured: Day 15 up to Day 43
Fraction of TRA excreted in feces (fe feces) (Period 1)
Feces is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Measured: Day 1 up to Day 14
Fraction of TRA excreted in feces (fe feces) (Period 2)
Feces is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Measured: Day 15 up to Day 43
Fraction of TRA excreted in vomitus (fe vomit) (Period 1)
Measured: At Day 1
Fraction of TRA excreted in vomitus (fe vomit) (Period 2)
Measured: At Day 15
Total fraction of TRA excreted (fe total) (Period 1)
The fe of TRA measured in urine, feces and vomitus (if applicable on Day 1 only). Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Measured: Day 1 up to Day 14
Total fraction of TRA excreted (fe total) (Period 2)
The fe of TRA measured in urine, feces and vomitus (if applicable on Day 15 only). Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Measured: Day 15 up to Day 43
Maximum concentration (Cmax) of VH4524184 in plasma (Period 1)
Measured: Day 1 to Day 14
Maximum concentration (Cmax) of VH4524184 in plasma (Period 2)
Measured: Day 15 to Day 43
Maximum concentration (Cmax) of [14C]VH4524184 in plasma (Period 1)
Measured: Day 1 to Day 14
Maximum concentration (Cmax) of TRA in plasma (Period 1)
Measured: Day 1 to Day 14
Maximum concentration (Cmax) of TRA in plasma (Period 2)
Measured: Day 15 to Day 43
Cmax of TRA in whole blood (Period 1)
Measured: Day 1 to Day 14
Cmax of TRA in whole blood (Period 2)
Measured: Day 15 to Day 43
Time to maximum concentration (tmax) of VH4524184 in plasma (Period 1)
Measured: Day 1 to Day 14
Time to maximum concentration (tmax) of VH4524184 in plasma (Period 2)
Measured: Day 15 to Day 43
Time to maximum concentration (tmax) of [14C]VH4524184 in plasma (Period 1)
Measured: Day 1 to Day 14
Time to maximum concentration (tmax) of TRA in plasma (Period 1)
Measured: Day 1 to Day 14
Time to maximum concentration (tmax) of TRA in plasma (Period 2)
Measured: Day 15 to Day 43
Time to maximum concentration (tmax) of TRA in whole blood (Period 1)
Measured: Day 1 to Day 14
Time to maximum concentration (tmax) of TRA in whole blood (Period 2)
Measured: Day 15 to Day 43
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of VH4524184 in plasma (Period 1)
Measured: Day 1 to Day 14
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of VH4524184 in plasma (Period 2)
Measured: Day 15 to Day 43
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of [14C]VH4524184 in plasma (Period 1)
Measured: Day 1 to Day 14
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in plasma (Period 1)
Measured: Day 1 to Day 14
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in plasma (Period 2)
Measured: Day 15 to Day 43
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in whole blood (Period 1)
Measured: Day 1 to Day 14
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in whole blood (Period 2)
Measured: Day 15 to Day 43
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of VH4524184 in plasma (Period 1)
Measured: Day 1 to Day 14
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of VH4524184 in plasma (Period 2)
Measured: Day 15 up to Day 43
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of [14C]VH4524184 in plasma (Period 1)
Measured: Day 1 to Day 14
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in plasma (Period 1)
Measured: Day 1 to Day 14
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in plasma (Period 2)
Measured: Day 15 to 43
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in whole blood (Period 1)
Measured: Day 1 to Day 14
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in whole blood (Period 2)
Measured: Day 15 to Day 43
Amount of VH4524184 excreted in urine (Ae urine) (Period 2)
Measured: Day 15 to Day 43
Fraction of VH4524184 excreted in urine (fe urine) (Period 2)
Measured: Day 15 to Day 43
Renal clearance of VH4524184 (CL R) (Period 2)
Measured: Day 15 to Day 43
Secondary outcomes (5)
Number of participants with adverse events (AE), overall and by severity (Periods 1 and 2)
Measured: Day 1 to Day 50
Number of participants who discontinue treatment due to AEs (Periods 1 and 2)
Measured: Day 1 to Day 50
Change from baseline for aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, and alkaline phosphatase (Periods 1 and 2)
Measured: On Days 2, 14, 16, 28 and 42
Maximum toxicity grade increase from baseline for AST, ALT, total bilirubin, and alkaline phosphatase (Periods 1 and 2)
Measured: On Days 2, 14, 16, 28 and 42
Blood to plasma ratio of TRA (Periods 1 and 2)
Cmax, AUC(0-t) and AUC(0-inf) TRA measured in whole blood compared to Cmax, AUC(0-t) and AUC(0-inf) TRA measured in plasma in Period 1 and Period 2.
Measured: Day 1 to Day 14 (Period 1) and Day 15 to Day 28 (Period 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start4 Jun 2026
- Primary completion20 Aug 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636928
- Sponsor's protocol ID
- 223803
- Other IDs
- 2026-525590-40
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single Dose Study to Assess the Absolute Bioavailability, Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]VH4524184 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07636928
- Acronym / sponsor ID
- 223803
- Conditions
- HIV Infections
- Keywords
- VH4524184, Human immunodeficiency virus (HIV)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VH4524184 Group | Experimental | Drug: VH4524184, Drug: [14C]VH4524184 microdose, Drug: [14C]VH4524184Participants will receive a dose of VH4524184 under fasting conditions, followed by a microdose of radiolabelled [14C]VH4524184 administered 2.5 hours after first dose administration at time zero on Day 1 (Period1). After a 14 days wash-out period participants will receive a radiolabelled dose of [14C]VH4524184 on Day 15 under fasting conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- Employee of ICON, the Sponsor, GSK or associated vendors.
- History of relevant drug and/or food allergies.
- History of drug hypersensitivity, delayed-type hypersensitivity, or severe hypersensitivity reactions, as well as history of sensitivity to the study drug.
- Using tobacco/nicotine products within 60 days prior to the first study drug administration.
- History of alcohol abuse or drug addiction within 5 years prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VH4524184One dose of VH4524184 is administered to participants at time zero on Day 1 (Period 1). | Drug | VH4524184 Group |
| [14C]VH4524184 microdoseA radiolabelled microdose of [14C]VH4524184 is administered 2.5 hours after VH4524184 dose administration on Day 1 (Period1). | Drug | VH4524184 Group |
| [14C]VH4524184One dose of radiolabelled [14C]VH4524184 is administered to participants at Day 15 (Period 2). | Drug | VH4524184 Group |
Primary outcome
Absolute bioavailability (F oral) of VH4524184 (Period 1)
Time frame: Day 1 up to Day 14
Amount of total radioactivity (TRA) excreted in urine (Ae urine) (Period 1)
Time frame: Day 1 up to Day 14
Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Amount of TRA excreted in urine (Ae urine) (Period 2)
Time frame: Day 15 up to Day 43
Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Amount of TRA excreted in feces (Ae feces) (Period 1)
Time frame: Day 1 up to Day 14
Feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Amount of TRA excreted in feces (Ae feces) (Period 2)
Time frame: Day 15 up to Day 43
Feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Amount of TRA excreted in vomitus (Ae vomit) (Period 1)
Time frame: At Day 1
Amount of TRA excreted in vomitus (Ae vomit) (Period 2)
Time frame: At Day 15
Total amount of TRA excreted (Ae total) (Period 1)
Time frame: From Day 1 up to Day 14
The Ae of TRA measured in urine, feces and vomitus (if applicable on Day 1 only). Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Total amount of TRA excreted (Ae total) (Period 2)
Time frame: Day 15 up to Day 43
The Ae of TRA measured in urine, feces and vomitus (if applicable on Day 15 only). Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Fraction of TRA excreted in urine (fe urine) (Period 1)
Time frame: Day 1 up to Day 14
Urine is collected until the amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Fraction of TRA excreted in urine (fe urine) (Period 2)
Time frame: Day 15 up to Day 43
Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Fraction of TRA excreted in feces (fe feces) (Period 1)
Time frame: Day 1 up to Day 14
Feces is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Fraction of TRA excreted in feces (fe feces) (Period 2)
Time frame: Day 15 up to Day 43
Feces is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Fraction of TRA excreted in vomitus (fe vomit) (Period 1)
Time frame: At Day 1
Fraction of TRA excreted in vomitus (fe vomit) (Period 2)
Time frame: At Day 15
Total fraction of TRA excreted (fe total) (Period 1)
Time frame: Day 1 up to Day 14
The fe of TRA measured in urine, feces and vomitus (if applicable on Day 1 only). Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Total fraction of TRA excreted (fe total) (Period 2)
Time frame: Day 15 up to Day 43
The fe of TRA measured in urine, feces and vomitus (if applicable on Day 15 only). Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
Maximum concentration (Cmax) of VH4524184 in plasma (Period 1)
Time frame: Day 1 to Day 14
Maximum concentration (Cmax) of VH4524184 in plasma (Period 2)
Time frame: Day 15 to Day 43
Maximum concentration (Cmax) of [14C]VH4524184 in plasma (Period 1)
Time frame: Day 1 to Day 14
Maximum concentration (Cmax) of TRA in plasma (Period 1)
Time frame: Day 1 to Day 14
Maximum concentration (Cmax) of TRA in plasma (Period 2)
Time frame: Day 15 to Day 43
Cmax of TRA in whole blood (Period 1)
Time frame: Day 1 to Day 14
Cmax of TRA in whole blood (Period 2)
Time frame: Day 15 to Day 43
Time to maximum concentration (tmax) of VH4524184 in plasma (Period 1)
Time frame: Day 1 to Day 14
Time to maximum concentration (tmax) of VH4524184 in plasma (Period 2)
Time frame: Day 15 to Day 43
Time to maximum concentration (tmax) of [14C]VH4524184 in plasma (Period 1)
Time frame: Day 1 to Day 14
Time to maximum concentration (tmax) of TRA in plasma (Period 1)
Time frame: Day 1 to Day 14
Time to maximum concentration (tmax) of TRA in plasma (Period 2)
Time frame: Day 15 to Day 43
Time to maximum concentration (tmax) of TRA in whole blood (Period 1)
Time frame: Day 1 to Day 14
Time to maximum concentration (tmax) of TRA in whole blood (Period 2)
Time frame: Day 15 to Day 43
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of VH4524184 in plasma (Period 1)
Time frame: Day 1 to Day 14
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of VH4524184 in plasma (Period 2)
Time frame: Day 15 to Day 43
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of [14C]VH4524184 in plasma (Period 1)
Time frame: Day 1 to Day 14
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in plasma (Period 1)
Time frame: Day 1 to Day 14
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in plasma (Period 2)
Time frame: Day 15 to Day 43
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in whole blood (Period 1)
Time frame: Day 1 to Day 14
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in whole blood (Period 2)
Time frame: Day 15 to Day 43
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of VH4524184 in plasma (Period 1)
Time frame: Day 1 to Day 14
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of VH4524184 in plasma (Period 2)
Time frame: Day 15 up to Day 43
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of [14C]VH4524184 in plasma (Period 1)
Time frame: Day 1 to Day 14
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in plasma (Period 1)
Time frame: Day 1 to Day 14
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in plasma (Period 2)
Time frame: Day 15 to 43
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in whole blood (Period 1)
Time frame: Day 1 to Day 14
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in whole blood (Period 2)
Time frame: Day 15 to Day 43
Amount of VH4524184 excreted in urine (Ae urine) (Period 2)
Time frame: Day 15 to Day 43
Fraction of VH4524184 excreted in urine (fe urine) (Period 2)
Time frame: Day 15 to Day 43
Renal clearance of VH4524184 (CL R) (Period 2)
Time frame: Day 15 to Day 43
5 secondary outcomes
Number of participants with adverse events (AE), overall and by severity (Periods 1 and 2)
Time frame: Day 1 to Day 50
Number of participants who discontinue treatment due to AEs (Periods 1 and 2)
Time frame: Day 1 to Day 50
Change from baseline for aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, and alkaline phosphatase (Periods 1 and 2)
Time frame: On Days 2, 14, 16, 28 and 42
Maximum toxicity grade increase from baseline for AST, ALT, total bilirubin, and alkaline phosphatase (Periods 1 and 2)
Time frame: On Days 2, 14, 16, 28 and 42
Blood to plasma ratio of TRA (Periods 1 and 2)
Time frame: Day 1 to Day 14 (Period 1) and Day 15 to Day 28 (Period 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VH4524184, [14C]VH4524184 microdose and [14C]VH4524184 in people with HIV Infections, run by ViiV Healthcare at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute bioavailability (F oral) of VH4524184 (Period 1) (time frame: Day 1 up to Day 14). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.