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HIV InfectionsPhase 1NCT07066722

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

A Phase 1 study testing VH4524184, Itraconazole and Rifabutin in people with HIV Infections, run by ViiV Healthcare at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
VH4524184, Itraconazole and Rifabutin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
2 sitesUnited States
Study dates
7 Jul 2025to 17 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1. Participants must be 18 to 60 years of age inclusive at the time of signing the Informed consent form (ICF).
  • 2. Male or female
  • 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).
  • 3. Participants who are overtly healthy as determined by medical evaluation 4. AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5 x Upper Limit of Normal (ULN) 6. Capable of giving signed informed consent.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.
  • History of seizure(s) and / or other clinically significant neurological conditions.
  • Pre-existing psychiatric condition, including depression, anxiety, and/or insomnia/sleep disturbances and / or suicidal ideation.
  • History of drug hypersensitivity.
  • 13. Use of medications/supplements affecting cytochrome P450 enzymes within 7 to 14 days prior to dosing.
  • 14. Contraindications based on selected drug prescribing information. 15. Exposure to more than 4 new investigational products within 12 months 16. Current enrollment or past participation in another investigational study in which an investigational intervention was administered within the last 30 days.
  • 17. Estimated glomelular filtration rate (eGFR) < 90 mL/min or serum creatinine >1.1×ULN [Inker, 2021].
  • 18. Hemoglobin <12.5 g/dL for men and <11 g/dL for women. 19. Presence of Hepatitis B surface antigen (HBsAg) [and Hepatitis B core antibody (HBcAb)] at screening 20. Positive Hepatitis C antibody test result at screening 21. Positive SARS-CoV-2 test, having signs and symptoms which in the opinion of the investigator are suggestive of COVID-19.
  • 22.Positive pre- study drug/alcohol screen. 23. Poor metabolizers of CYP2C9 and / or CYP2C19 as assessed by genotype testing. HLA-B1502 positive as applicable to specified cohort.
  • Other exclusion criteria 24. Regular alcohol consumption exceeding specified limits. 25. Regular use of known drugs of abuse. 26. Nicotine use within 6 months. 27. Sensitivity or allergy to the study drug. 28. ALT >1.5×ULN. 29. Total bilirubin >1.5×ULN. 30. Significant arrhythmias or ECG findings that may compromise participant safety according to the investigator or VH Medical Monitor's assessment.
  • 31. For eligibility determination, triplicate ECGs are required. The criteria are:
  • Heart Rate: Excludes males with <45 or >100 bpm, females with <50 or >100 bpm.
  • PR Interval: Excludes any PR intervals <120 or >220 msec.
  • QRS Duration: Excludes durations <70 or >120 msec.
  • QTcF Interval: Excludes intervals >450 msec.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • GSK Investigational Site

    Lenexa, Kansas, 66219

  • GSK Investigational Site

    Salt Lake City, Utah, 84124

Other trials in United States

About this study

Official title: A Phase 1, Open-Label Study to Evaluate the Relative Bioavailability and the Effect of Food on VH4524184 Tablet Formulations, and to Evaluate the Potential for VH4524184 Drug-Drug-Interactions in Healthy Adult Participants

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.

Conditions
HIV Infections
Being tested
VH4524184, Itraconazole, Rifabutin, Phenytoin, Metformin
Keywords
Drug-drug interaction, First-time in human, HIV, Bioavailability, Healthy Adult Participants
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VH4524184Drug

    VH4524184 will be administered.

  • ItraconazoleDrug

    Also called Sporanox

    Itraconazole will be administered.

  • RifabutinDrug

    Also called Mycobutin

    Rifabutin will be administered.

  • PhenytoinDrug

    Also called Dilantin

    Extended phenytoin sodium will be administered.

  • MetforminDrug

    Also called Glumetza

    Metformin will be administered.

  • DigoxinDrug

    Also called Lanoxin

    Digoxin will be administered.

Study groups in NCT07066722
Study groupRoleWhat they receive
Part 1A_VH4524184 (Sequence 1)ExperimentalParticipants will receive VH4524184 tablet(s) of Dose level 1 followed by Dose level 2 in fasted condition.
Receives: Drug: VH4524184
Part 1A_VH4524184 (Sequence 2)ExperimentalParticipants will receive VH4524184 tablet(s) of Dose level 2 followed by Dose level 1 in fasted condition.
Receives: Drug: VH4524184
Part 1A_VH4524184 (Sequence 3)ExperimentalParticipants will receive VH4524184 tablet(s) of Dose level 3 followed by Dose level 2 in fasted condition.
Receives: Drug: VH4524184
Part 1A_VH4524184 (Sequence 4)ExperimentalParticipants will receive VH4524184 tablet(s) of Dose level 2 followed by Dose level 3 in fasted condition.
Receives: Drug: VH4524184
Part 1B_VH4524184 (Sequence 5)ExperimentalParticipants will receive VH4524184 tablet of Dose level 2 in fasted condition and then followed by intake of a high fat meal.
Receives: Drug: VH4524184
Part 1B_VH4524184 Sequence 6)ExperimentalParticipants will receive VH4524184 tablet of Dose level 2 following a high fat meal and then in fasted condition.
Receives: Drug: VH4524184
Part 1B_VH4524184 (Sequence 7)ExperimentalParticipants will receive VH4524184 tablet of Dose level 3 in fasted condition and then followed by intake of a high fat meal.
Receives: Drug: VH4524184
Part 1B_VH4524184 (Sequence 8)ExperimentalParticipants will receive VH4524184 tablet of Dose level 3 following a high fat meal and then in a fasted condition.
Receives: Drug: VH4524184
Part 2_Cohort 1ExperimentalParticipants will receive VH4524184 tablet and Itraconazole.
Receives: Drug: VH4524184; Drug: Itraconazole
Part 2_Cohort 2AExperimentalParticipants will receive VH4524184 and Rifabutin.
Receives: Drug: VH4524184; Drug: Rifabutin
Part 2_Cohort 2BExperimentalParticipants will receive VH4524184 tablet and Phenytoin.
Receives: Drug: VH4524184; Drug: Phenytoin
Part 2_ Cohort 3ExperimentalParticipants will receive Metformin, Digoxin and VH4524184 tablets.
Receives: Drug: VH4524184; Drug: Metformin; Drug: Digoxin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Maximum plasma concentration (Cmax) for VH4524184

    Measured: Up to Day 18

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

    Measured: Up to day 18

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

    Measured: Up to day 18

  4. Part 2: Cmax for VH4524184

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

  5. Part 2: AUC0-t of VH4524184

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

  6. Part 2: AUC0-inf of VH4524184

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

  7. Part 2: Cmax for metformin

    Measured: At Day 1 and Day 15

  8. Part 2: AUC0-t for metformin

    Measured: At Day 1 and Day 15

  9. Part 2: Cmax for Digoxin

    Measured: At Day 1 and Day 15

  10. Part 2: AUC0-t for Digoxin

    Measured: At Day 1 and Day 15

Secondary outcomes (18)

  1. Number of participants with adverse events (AEs) and severity of AEs

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity of grades are defined as Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially Life- Threatening.

    Measured: From Day 1 up to Day 42

  2. Number of participants with AEs leading to discontinuation of study intervention

    Measured: Throughout the study treatment period (from Day 1 up to Day 33)

  3. Number of participants with Change in laboratory parameters

    Measured: From Day 1 up to Day 42

  4. Number of participants with maximum toxicity grade increase from baseline in laboratory parameters

    Toxicity is graded using the DAIDS criteria Version 2.1 where grades were defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: potentially life-threatening. A higher grade indicates greater severity.

    Measured: From Day 1 up to Day 42

  5. Part 1: Time to maximum concentration (Tmax) of VH4524184

    Measured: At Day 1

  6. Part 1: Apparent Terminal Half Life (T1/2) of VH4524184

    Measured: At Day 1

  7. Part 1: Apparent oral clearance (CL/F) of VH4524184

    Measured: At Day 1

  8. Part 2: Tmax of VH4524184 Following Single-Dose Administration with CYP3A4 Inhibitors and Inducers (Itraconazole, Rifabutin, Phenytoin)

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

  9. Part 2: T1/2 of VH4524184 Following Single-Dose Administration with CYP3A4 Inhibitors and Inducers (Itraconazole, Rifabutin, Phenytoin)

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

  10. Part 2: CL/F of VH4524184 Following Single-Dose Administration with CYP3A4 Inhibitors and Inducers (Itraconazole, Rifabutin, Phenytoin)

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

  11. Part 2: Cmax for VH5424184 Following Comedication with Transporter Substrates with metformin and digoxin

    Measured: At Day 1 and Day 15

  12. Part 2: AUC0-t for VH5424184 Following Comedication with Transporter Substrates metformin and digoxin

    Measured: At Day 1 and Day 15

  13. Part 2: Cmax for Itraconazole Following Comedication with VH4524184

    Measured: At Day 1 and Day 14

  14. Part 2: AUC0-t for Itraconazole Following Comedication with VH4524184

    Measured: At Day 1 and Day 14

  15. Part 2: Cmax for Rifabutin Following Comedication with VH4524184

    Measured: At Day 1 and Day 11

  16. Part 2: AUC0-t for Rifabutin Following Comedication with VH4524184

    Measured: At Day 1 and Day 19

  17. Part 2: Cmax for Phenytoin Following Comedication with VH4524184

    Measured: Day 1 and Day 22

  18. Part 2: AUC0-t for Phenytoin Following Comedication with VH4524184

    Measured: Day 1 and Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2025
  2. Study start7 Jul 2025
  3. Primary completion17 Dec 2025
  4. Study completion17 Dec 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07066722
Sponsor's protocol ID
219890
Status last verified
Mar 2026
First submitted
3 Jul 2025
Last updated
9 Mar 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VH4524184, Itraconazole and Rifabutin in people with HIV Infections, run by ViiV Healthcare at 2 sites in United States.

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 5 inclusion and 22 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: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Maximum plasma concentration (Cmax) for VH4524184 (time frame: Up to Day 18). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07066722.

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 9 Mar 2026.

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