> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-vh4524184-tablet-absorption-effects-of-fc458ac4-ca71-467e-8632-4041da6e8468 > Record changed: 2026-11-04 # A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults NCT07066722 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) Participants 126 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) Lead sponsor ViiV Healthcare Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) Start date 2025-07-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Short title** A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) ## Dates **Completion date** 2025-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **First posted** 2025-07-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Registry last updated** 2026-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Primary completion date** 2025-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Start date** 2025-07-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) ## Size and sites **Actual participants** 126 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Participants** 126 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Lead sponsor** ViiV Healthcare Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) ## Identifiers **Registry ID** NCT07066722 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **ClinicalTrials.gov ID** NCT07066722 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) ## Study design **Allocation** Randomised **Model** Crossover **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** Yes ### 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. 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) ## Sites - GSK Investigational SiteLenexa, United States - GSK Investigational SiteSalt Lake City, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07066722) ## Related records ### Drugs (5) - [Digoxin](https://trialight.com/data/asset/digoxin-9928e38a-813e-4948-9d65-9088ba40a442.md) - [Itraconazole](https://trialight.com/data/asset/itraconazole-c6f2473e-393a-44a9-8969-8d501b15ef65.md) - [Metformin](https://trialight.com/data/asset/metformin-0292cbe3-3a2f-4db7-b783-270ef048c3b4.md) - [Phenytoin](https://trialight.com/data/asset/phenytoin-44a950d0-f94b-4230-8b1e-9881f4334eb2.md) - [Rifabutin](https://trialight.com/data/asset/rifabutin-8397100e-1164-43cd-814a-11120a1f39fe.md) ### Lead sponsors (1) - [ViiV Healthcare](https://trialight.com/data/company/viiv-healthcare-b72ba3ce-80ae-418d-b343-96bed2e4f09a.md) ### Conditions (1) - [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Primary condition ### Targets (69) - [ATP1A1](https://trialight.com/data/target/atp1a1-00e60877-1637-5837-b618-ba0116f706f8.md) - [ATP1A2](https://trialight.com/data/target/atp1a2-5407dcad-093d-5dcb-99a8-af782af823c9.md) - [ATP1A3](https://trialight.com/data/target/atp1a3-59f6fc7c-a0db-530e-979b-044e2f23b9eb.md) - [ATP1A4](https://trialight.com/data/target/atp1a4-d5da371a-13f7-50be-babb-04e116f82c3c.md) - [ATP1B1](https://trialight.com/data/target/atp1b1-cd8feef1-fad0-52f3-96d3-56125fa8266f.md) - [ATP1B2](https://trialight.com/data/target/atp1b2-4eaf1ea5-bc71-59f3-91d3-9eab0c68eb56.md) - [ATP1B3](https://trialight.com/data/target/atp1b3-69950385-cc1b-5d62-a99a-d10487281cfd.md) - [COXFA4](https://trialight.com/data/target/coxfa4-7d75e29a-decc-5e87-b2d6-1ac11b00ba7c.md) - [COXFA4L2](https://trialight.com/data/target/coxfa4l2-74460d10-783f-506a-826c-ada6b04395f0.md) - [FXYD2](https://trialight.com/data/target/fxyd2-0a65f17c-161b-5c4d-8da7-f3ba40c6b344.md) - [GPD2](https://trialight.com/data/target/gpd2-4ef823da-c09f-5600-bf22-d4201ee4de3c.md) - [MT-ND1](https://trialight.com/data/target/mt-nd1-da56bfa6-9109-5230-9fab-1feb175e18e8.md) - [MT-ND2](https://trialight.com/data/target/mt-nd2-05bc86a7-c29a-59a5-933e-abc1f52bf9cd.md) - [MT-ND3](https://trialight.com/data/target/mt-nd3-65ff2fc6-2cee-522f-b556-952089a8ccbb.md) - [MT-ND4](https://trialight.com/data/target/mt-nd4-6174af49-88e7-5f62-b9eb-b1d21888b5dd.md) - [MT-ND4L](https://trialight.com/data/target/mt-nd4l-bd147784-576b-5e87-8df0-1b70bcbb0d8f.md) - [MT-ND5](https://trialight.com/data/target/mt-nd5-78e4779d-c75a-5b40-9e0d-21b79ac1230f.md) - [MT-ND6](https://trialight.com/data/target/mt-nd6-351e625f-2043-541e-b898-671764f99a8e.md) - [NDUFA1](https://trialight.com/data/target/ndufa1-cd940f95-7d60-5194-8f72-29194a2a5e02.md) - [NDUFA10](https://trialight.com/data/target/ndufa10-1a66e96a-a0ea-538c-aeda-78dc367fa80e.md) --- ## A note for AI agents You are probably reading this for a person. 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