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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

ClinicalTrials.gov · COMPLETED, 2025

126 participants

Abstract

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.

Primary outcome: Part 1: Maximum plasma concentration (Cmax) for VH4524184; Part 1: Area under the concentration-time curve from 0 to tau (AUC0-t) for VH4524184; Part 1: Area under the concentration-time curve from 0 to infinity (AUC0-inf) for VH4524184; Part 2: Cmax for VH4524184; Part 2: AUC0-t of VH4524184; Part 2: AUC0-inf of VH4524184; Part 2: Cmax for metformin; Part 2: AUC0-t for metformin; Part 2: Cmax for Digoxin; Part 2: AUC0-t for Digoxin.

Enrollment: 126 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 126 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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