RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-07-07

Study Completion:2025-11-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07066722

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
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).	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. 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. Medical history of cardiac arrhythmias or cardiac disease or a family long QT syndrome. 9. History of seizure(s) and / or other neurological conditions. 10. Pre-existing psychiatric condition, including depression, anxiety, and/or insomnia/sleep disturbances and / or suicidal ideation. 11. History of drug hypersensitivity. 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. 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.

Inclusion Criteria

Exclusion Criteria

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).

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. 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. Medical history of cardiac arrhythmias or cardiac disease or a family long QT syndrome.
9. History of seizure(s) and / or other neurological conditions.
10. Pre-existing psychiatric condition, including depression, anxiety, and/or insomnia/sleep disturbances and / or suicidal ideation.
11. History of drug hypersensitivity.
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.
* 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.

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center

CONTACT

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

Study Locations (Sites)

GSK Investigational Site

Lenexa, Kansas, 66219

United States

GSK Investigational Site

Salt Lake City, Utah, 84124

United States

Collaborators and Investigators

Sponsor: ViiV Healthcare

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-07

Study Completion Date2025-11-06

Study Record Updates

Study Start Date2025-07-07

Study Completion Date2025-11-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

HIV Infections