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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID

NCT06368986

Run by

ViiV Healthcare

People needed

60

Starts

2024-04-17

Expected to finish

2024-10-02

Last updated by the study team

2025-02-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants who are 18 to 55 years of age.
• Participants who are overtly healthy.
• One SARs-CoV-2 negative test is required prior to dosing
• Body weight within 50-100 kg and body mass index (BMI) within the range 19-32 kg/m2 (inclusive).
• Capable of giving signed informed consent.
• Participants male at birth must use male condoms, and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.

You may not qualify if…

• History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
• Current or chronic liver disease, hepatic or biliary abnormalities, or relevant hepatitis.
• Abnormal blood pressure.
• Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years. Participants with exclusionary electrocardiogram findings.Positive HIV test or ongoing behaviors that put the participant at high risk for HIV acquisition.
• Participants who are breastfeeding or plan to become pregnant during the study.
• Past or intended use of exclusionary medications or vaccines.
• Exposure to >4 new investigational products within 12 months, previous participation in this study, or current enrolment or participation in another investigational study.
• ALT >1.5x upper limit of normal (ULN), total bilirubin >1.5x ULN, and/or estimated serum creatinine clearance <60 mL/min.
• History of or current infection with hepatitis B or hepatitis C.
• Positive SARS-CoV-2 test, having signs and symptoms suggestive of COVID-19, or contact with known COVID-19 positive person.
• Positive HIV antibody test.
• Participants with positive results for illicit drug use, regular use of drugs of abuse, tobacco or nicotine-containing product use, and/or excessive alcohol use.

Where it is running

• GSK Investigational Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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