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

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: VH4011499 Dose B; Drug: VH4011499 Dose A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06368986

222420

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 5 patient groups

Part 1 Dose A - Fasted condition

Experimental group

Description:

VH4011499 Dose A tablet administered in fasted condition.

Treatment:

Drug: VH4011499 Dose A

Part 1 Dose A- Fed condition (high fat meal)

Experimental group

Description:

VH4011499 Dose A tablet administered in fed condition (high fat meal).

Treatment:

Drug: VH4011499 Dose A

Part 2 Dose B - Optional - Fed condition (low fat meal)

Experimental group

Description:

VH4011499 Dose B tablet administered in fed condition (low fat meal).

Treatment:

Drug: VH4011499 Dose B

Part 3 Dose B - Fasted condition

Experimental group

Description:

VH4011499 Dose B tablet administered in fasted condition.

Treatment:

Drug: VH4011499 Dose B

Part 3 Dose B - Fed condition (high fat meal)

Experimental group

Description:

VH4011499 Dose B tablet administered in fed condition (high fat meal).

Treatment:

Drug: VH4011499 Dose B