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

NCT07066722 | Completed Phase 1 FDA Drug

• 1 other identifier: 219890
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (10)

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

  Up to Day 18

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

  Up to day 18

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

  Up to day 18

• Part 2: Cmax for VH4524184

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

• Part 2: AUC0-t of VH4524184

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

• Part 2: AUC0-inf of VH4524184

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

• Part 2: Cmax for metformin

  At Day 1 and Day 15

• Part 2: AUC0-t for metformin

  At Day 1 and Day 15

• Part 2: Cmax for Digoxin

  At Day 1 and Day 15

• Part 2: AUC0-t for Digoxin

  At Day 1 and Day 15

Secondary Outcomes (18)

• Number of participants with adverse events (AEs) and severity of AEs

  From Day 1 up to Day 42

• Number of participants with AEs leading to discontinuation of study intervention

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

• Number of participants with Change in laboratory parameters

  From Day 1 up to Day 42

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

  From Day 1 up to Day 42

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

  At Day 1

Study Arms (12)

Part 1A_VH4524184 (Sequence 1)

EXPERIMENTAL

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

Drug: VH4524184

Part 1A_VH4524184 (Sequence 2)

EXPERIMENTAL

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

Drug: VH4524184

Part 1A_VH4524184 (Sequence 3)

EXPERIMENTAL

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

Drug: VH4524184

Part 1A_VH4524184 (Sequence 4)

EXPERIMENTAL

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

Drug: VH4524184

Part 1B_VH4524184 (Sequence 5)

EXPERIMENTAL

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

Drug: VH4524184

Part 1B_VH4524184 Sequence 6)

EXPERIMENTAL

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

Drug: VH4524184

Part 1B_VH4524184 (Sequence 7)

EXPERIMENTAL

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

Drug: VH4524184

Part 1B_VH4524184 (Sequence 8)

EXPERIMENTAL

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

Drug: VH4524184

Part 2_Cohort 1

EXPERIMENTAL

Participants will receive VH4524184 tablet and Itraconazole.

Drug: VH4524184; Drug: Itraconazole

Part 2_Cohort 2A

EXPERIMENTAL

Participants will receive VH4524184 and Rifabutin.

Drug: VH4524184; Drug: Rifabutin

Part 2_Cohort 2B

EXPERIMENTAL

Participants will receive VH4524184 tablet and Phenytoin.

Drug: VH4524184; Drug: Phenytoin

Part 2_ Cohort 3

EXPERIMENTAL

Participants will receive Metformin, Digoxin and VH4524184 tablets.

Drug: VH4524184; Drug: Metformin; Drug: Digoxin

Interventions

VH4524184 DRUG

VH4524184 will be administered.

Part 1A_VH4524184 (Sequence 1); Part 1A_VH4524184 (Sequence 2); Part 1A_VH4524184 (Sequence 3); Part 1A_VH4524184 (Sequence 4); Part 1B_VH4524184 (Sequence 5); Part 1B_VH4524184 (Sequence 7); Part 1B_VH4524184 (Sequence 8); Part 1B_VH4524184 Sequence 6); Part 2_ Cohort 3; Part 2_Cohort 1; Part 2_Cohort 2A; Part 2_Cohort 2B

Rifabutin DRUG

Rifabutin will be administered.

Also known as: Mycobutin

Part 2_Cohort 2A

Phenytoin DRUG

Extended phenytoin sodium will be administered.

Also known as: Dilantin

Part 2_Cohort 2B

Metformin DRUG

Metformin will be administered.

Also known as: Glumetza

Part 2_ Cohort 3

Digoxin DRUG

Digoxin will be administered.

Also known as: Lanoxin

Part 2_ Cohort 3

Itraconazole DRUG

Itraconazole will be administered.

Also known as: Sporanox

Part 2_Cohort 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Participants must be 18 to 60 years of age inclusive at the time of signing the Informed consent form (ICF).
• \. 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).
• \. 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.

You may not qualify if:

• 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.
• 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.
• \. Use of medications/supplements affecting cytochrome P450 enzymes within 7 to 14 days prior to dosing.
• \. 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.
• \. Estimated glomelular filtration rate (eGFR) \< 90 mL/min or serum creatinine \>1.1×ULN \[Inker, 2021\].
• \. 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.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (2)

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Itraconazole; Rifabutin; Phenytoin; Metformin; Digoxin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Hydantoins; Imidazolidines; Imidazoles; Biguanides; Guanidines; Amidines; Organic Chemicals; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 15, 2025
• Study Start: July 7, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

US (2)