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

NCT ID: NCT06368986

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2024-10-02

Brief Summary

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

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Part 1 Dose A - Fasted condition

VH4011499 Dose A tablet administered in fasted condition.

Group Type: EXPERIMENTAL

VH4011499 Dose A

Intervention Type: DRUG

VH4011499 administered in fasted or fed conditions.

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

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

Group Type: EXPERIMENTAL

VH4011499 Dose A

Intervention Type: DRUG

VH4011499 administered in fasted or fed conditions.

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

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

Group Type: EXPERIMENTAL

VH4011499 Dose B

Intervention Type: DRUG

VH4011499 Dose B administered in fasted or fed conditions.

Part 3 Dose B - Fasted condition

VH4011499 Dose B tablet administered in fasted condition.

Group Type: EXPERIMENTAL

VH4011499 Dose B

Intervention Type: DRUG

VH4011499 Dose B administered in fasted or fed conditions.

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

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

Group Type: EXPERIMENTAL

VH4011499 Dose B

Intervention Type: DRUG

VH4011499 Dose B administered in fasted or fed conditions.

Interventions

VH4011499 Dose A

VH4011499 administered in fasted or fed conditions.

Intervention Type: DRUG

VH4011499 Dose B

VH4011499 Dose B administered in fasted or fed conditions.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ViiV Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Austin, Texas, United States

Countries

United States

Other Identifiers

222420

Identifier Type: -

Identifier Source: org_study_id