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

NCT ID: NCT07066722

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-07

Study Completion Date

2025-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Keywords

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Drug-drug interaction First-time in human HIV Bioavailability Healthy Adult Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1A_VH4524184 (Sequence 1)

Participants will receive VH4524184 tablet(s) of Dose level 1 followed by Dose level 2 in fasted condition.

Group Type EXPERIMENTAL

VH4524184

Intervention Type DRUG

VH4524184 will be administered.

Part 1A_VH4524184 (Sequence 2)

Participants will receive VH4524184 tablet(s) of Dose level 2 followed by Dose level 1 in fasted condition.

Group Type EXPERIMENTAL

VH4524184

Intervention Type DRUG

VH4524184 will be administered.

Part 1A_VH4524184 (Sequence 3)

Participants will receive VH4524184 tablet(s) of Dose level 3 followed by Dose level 2 in fasted condition.

Group Type EXPERIMENTAL

VH4524184

Intervention Type DRUG

VH4524184 will be administered.

Part 1A_VH4524184 (Sequence 4)

Participants will receive VH4524184 tablet(s) of Dose level 2 followed by Dose level 3 in fasted condition.

Group Type EXPERIMENTAL

VH4524184

Intervention Type DRUG

VH4524184 will be administered.

Part 1B_VH4524184 (Sequence 5)

Participants will receive VH4524184 tablet of Dose level 2 in fasted condition and then followed by intake of a high fat meal.

Group Type EXPERIMENTAL

VH4524184

Intervention Type DRUG

VH4524184 will be administered.

Part 1B_VH4524184 Sequence 6)

Participants will receive VH4524184 tablet of Dose level 2 following a high fat meal and then in fasted condition.

Group Type EXPERIMENTAL

VH4524184

Intervention Type DRUG

VH4524184 will be administered.

Part 1B_VH4524184 (Sequence 7)

Participants will receive VH4524184 tablet of Dose level 3 in fasted condition and then followed by intake of a high fat meal.

Group Type EXPERIMENTAL

VH4524184

Intervention Type DRUG

VH4524184 will be administered.

Part 1B_VH4524184 (Sequence 8)

Participants will receive VH4524184 tablet of Dose level 3 following a high fat meal and then in a fasted condition.

Group Type EXPERIMENTAL

VH4524184

Intervention Type DRUG

VH4524184 will be administered.

Part 2_Cohort 1

Participants will receive VH4524184 tablet and Itraconazole.

Group Type EXPERIMENTAL

VH4524184

Intervention Type DRUG

VH4524184 will be administered.

Itraconazole

Intervention Type DRUG

Itraconazole will be administered.

Part 2_Cohort 2A

Participants will receive VH4524184 and Rifabutin.

Group Type EXPERIMENTAL

VH4524184

Intervention Type DRUG

VH4524184 will be administered.

Rifabutin

Intervention Type DRUG

Rifabutin will be administered.

Part 2_Cohort 2B

Participants will receive VH4524184 tablet and Phenytoin.

Group Type EXPERIMENTAL

VH4524184

Intervention Type DRUG

VH4524184 will be administered.

Phenytoin

Intervention Type DRUG

Extended phenytoin sodium will be administered.

Part 2_ Cohort 3

Participants will receive Metformin, Digoxin and VH4524184 tablets.

Group Type EXPERIMENTAL

VH4524184

Intervention Type DRUG

VH4524184 will be administered.

Metformin

Intervention Type DRUG

Metformin will be administered.

Digoxin

Intervention Type DRUG

Digoxin will be administered.

Interventions

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VH4524184

VH4524184 will be administered.

Intervention Type DRUG

Itraconazole

Itraconazole will be administered.

Intervention Type DRUG

Rifabutin

Rifabutin will be administered.

Intervention Type DRUG

Phenytoin

Extended phenytoin sodium will be administered.

Intervention Type DRUG

Metformin

Metformin will be administered.

Intervention Type DRUG

Digoxin

Digoxin will be administered.

Intervention Type DRUG

Other Intervention Names

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Sporanox Mycobutin Dilantin Glumetza Lanoxin

Eligibility Criteria

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Inclusion Criteria

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

1. Male Participants: No restrictions for male participants
2. 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.

Exclusion Criteria

1. History or presence of clinical conditions affecting drug absorption, metabolism, or elimination.,
2. Pre-existing clinically relevant, gastro-intestinal pathology
3. Abnormal glucose metabolism requiring insulin or medications.
4. Clinically significant Abnormal blood pressure.
5. History of Lymphoma, leukemia, or any malignancy within the past 5 years (3 years for resected basal or squamous epithelial carcinomas of skin).
6. Breast cancer within the past 10 years.
7. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
8. History of syncope, clinically significant palpitations, cardiac arrhythmias or cardiac disease or a family long QT syndrome.
9. History of seizure(s) and / or other clinically significant neurological conditions.
10. Pre-existing psychiatric condition, including depression, anxiety, and/or insomnia/sleep disturbances and / or suicidal ideation.
11. 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-B\*1502 positive as applicable to specified cohort.


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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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GSK Investigational Site

Lenexa, Kansas, United States

Site Status RECRUITING

GSK Investigational Site

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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US GSK Clinical Trials Call Center

Role: CONTACT

Phone: 877-379-3718

Email: [email protected]

EU GSK Clinical Trials Call Center

Role: CONTACT

Phone: +44 (0) 20 89904466

Email: [email protected]

Facility Contacts

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US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

Other Identifiers

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219890

Identifier Type: -

Identifier Source: org_study_id