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

NCT07066722
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Phase
Phase 1
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Recruitment status
Completed
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Participants
126
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Lead sponsor
ViiV Healthcare
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Start date
2025-07-07
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Number of sites
2
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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.
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Short title
A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-12-17
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First posted
2025-07-15
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Registry last updated
2026-03-09
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Primary completion date
2025-12-17
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Start date
2025-07-07
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Actual participants
126
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Participants
126
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
2
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
ViiV Healthcare
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07066722
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ClinicalTrials.gov ID
NCT07066722
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Registry record
Open registry record
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Allocation
Randomised
Model
Crossover
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Part 1: Maximum plasma concentration (Cmax) for VH4524184

    Timeframe: Up to Day 18

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

    Timeframe: Up to day 18

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

    Timeframe: Up to day 18

  4. Part 2: Cmax for VH4524184

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

  5. Part 2: AUC0-t of VH4524184

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

  6. Part 2: AUC0-inf of VH4524184

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

  7. Part 2: Cmax for metformin

    Timeframe: At Day 1 and Day 15

  8. Part 2: AUC0-t for metformin

    Timeframe: At Day 1 and Day 15

  9. Part 2: Cmax for Digoxin

    Timeframe: At Day 1 and Day 15

  10. Part 2: AUC0-t for Digoxin

    Timeframe: At Day 1 and Day 15

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

    Timeframe: From Day 1 up to Day 42

    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.

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

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

  3. Number of participants with Change in laboratory parameters

    Timeframe: From Day 1 up to Day 42

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

    Timeframe: From Day 1 up to Day 42

    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.

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

    Timeframe: At Day 1

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

    Timeframe: At Day 1

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

    Timeframe: At Day 1

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

    Timeframe: 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)

    Timeframe: 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)

    Timeframe: 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

    Timeframe: At Day 1 and Day 15

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

    Timeframe: At Day 1 and Day 15

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

    Timeframe: At Day 1 and Day 14

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

    Timeframe: At Day 1 and Day 14

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

    Timeframe: At Day 1 and Day 11

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

    Timeframe: At Day 1 and Day 19

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

    Timeframe: Day 1 and Day 22

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

    Timeframe: Day 1 and Day 22

Sources for outcomes
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Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
60 Years
Healthy volunteers
Yes

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.

  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.

    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.
Sources for eligibility
clinicaltrials.gov

  • GSK Investigational SiteLenexa, United States
  • GSK Investigational SiteSalt Lake City, United States
Sources for sites
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