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A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants - Trial NCT06368986

Access comprehensive clinical trial information for NCT06368986 through Pure Global AI's free database. This Phase 1 trial is sponsored by ViiV Healthcare and is currently Not yet recruiting. The study focuses on HIV Infections. Target enrollment is 36 participants.

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NCT06368986
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06368986
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A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants
An Open Label, Phase 1 Study to Assess the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in Healthy Adult Participants

Study Focus

HIV Infections

VH4011499

Interventional

drug

Sponsor & Location

ViiV Healthcare

Timeline & Enrollment

Phase 1

Apr 16, 2024

Jun 12, 2024

36 participants

Primary Outcome

Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499,Area under the plasma drug concentration - time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tlast) of VH4011499,Maximum observed plasma drug concentration (Cmax) of VH4011499,Time to maximum observed plasma concentration (Tmax) of VH4011499

Summary

The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the
 bioavailability of CAI VH4011499.

ICD-10 Classifications

HIV disease resulting in other viral infections
HIV disease resulting in other bacterial infections
HIV disease resulting in multiple infections
Acute HIV infection syndrome
HIV disease resulting in other infectious and parasitic diseases

Data Source

ClinicalTrials.gov

NCT06368986

Non-Device Trial