A Study to Investigate the Relative Bioavailability and Food Effect of an Oral Capsid Inhibitor Tablet Formulation Compared With Other Oral Tablet Formulations in Male and Female Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-18

Study Completion Date

2024-06-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a 3 part study of an investigational capsid inhibitor, VH4004280, in healthy adult participants. The purpose is to evaluate the effect of tablet formulation as well as food on bioavailability. Part 1 of the study will compare the relative bioavailability of VH4004280 Formulation A tablets to up to 4 alternative tablet formulations under fed (high fat) conditions. Part 2 of the study will assess the effect of fasted conditions on the bioavailability of VH4004280 Formulation A and alternative, optional formulations, relative to their respective bioavailability under fed conditions in Part 1. The optional Part 3 of the study will assess relative bioavailability of VH4004280 Formulation A to up to 3 alternative formulations, selected from Regimens B, C or D, under fed (lower fat) conditions.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Relative Bioavailability and Food-Effect Study of GSK3640254 Tablet and Capsule Formulations in Healthy Participants

NCT04263142

HIV Infections

COMPLETED PHASE1

A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation

NCT05776108

HIV Infections

COMPLETED PHASE1

A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435

NCT01209117

Infections, Human Immunodeficiency Virus and Herpesviridae Infection, Human Immunodeficiency Virus

COMPLETED PHASE1

A Study to Compare the Relative Bioavailability of Two Different Formulations of GSK3640254

NCT03575962

HIV Infections

COMPLETED PHASE1

A Study of the Relative Bioavailability of Single Dose RO4917838 and the Effect of Food in Healthy Volunteers

NCT01665976

Healthy Volunteer

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1 - Regimen A

VH4004280 Formulation A tablet administered in fed conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation A

Intervention Type DRUG

Oral administration of VH4004280 Formulation A in fasted or fed conditions.

Part 1 - Regimen B

VH4004280 Formulation B tablet administered in fed conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation B

Intervention Type DRUG

Oral administration of VH4004280 Formulation B in fasted or fed conditions.

Part 1 - Regimen C

VH4004280 Formulation C tablet administered in fed conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation C

Intervention Type DRUG

Oral administration of VH4004280 Formulation C in fasted or fed conditions.

Part 1 - Optional Regimen D

VH4004280 Formulation D tablet administered in fed conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation D

Intervention Type DRUG

Oral administration of VH4004280 Formulation D in fasted or fed conditions.

Part 1 - Optional Regimen E

VH4004280 Formulation E tablet administered in fed conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation E

Intervention Type DRUG

Oral administration of VH4004280 Formulation E in fasted or fed conditions.

Part 2 - Regimen A

VH4004280 Formulation A tablet administered in fasted conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation A

Intervention Type DRUG

Oral administration of VH4004280 Formulation A in fasted or fed conditions.

Part 2- Optional Regimen 1

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation B

Intervention Type DRUG

Oral administration of VH4004280 Formulation B in fasted or fed conditions.

VH4004280 Formulation C

Intervention Type DRUG

Oral administration of VH4004280 Formulation C in fasted or fed conditions.

VH4004280 Formulation D

Intervention Type DRUG

Oral administration of VH4004280 Formulation D in fasted or fed conditions.

VH4004280 Formulation E

Intervention Type DRUG

Oral administration of VH4004280 Formulation E in fasted or fed conditions.

Part 2- Optional Regimen 2

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation B

Intervention Type DRUG

Oral administration of VH4004280 Formulation B in fasted or fed conditions.

VH4004280 Formulation C

Intervention Type DRUG

Oral administration of VH4004280 Formulation C in fasted or fed conditions.

VH4004280 Formulation D

Intervention Type DRUG

Oral administration of VH4004280 Formulation D in fasted or fed conditions.

VH4004280 Formulation E

Intervention Type DRUG

Oral administration of VH4004280 Formulation E in fasted or fed conditions.

Part 2- Optional Regimen 3

VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation B

Intervention Type DRUG

Oral administration of VH4004280 Formulation B in fasted or fed conditions.

VH4004280 Formulation C

Intervention Type DRUG

Oral administration of VH4004280 Formulation C in fasted or fed conditions.

VH4004280 Formulation D

Intervention Type DRUG

Oral administration of VH4004280 Formulation D in fasted or fed conditions.

VH4004280 Formulation E

Intervention Type DRUG

Oral administration of VH4004280 Formulation E in fasted or fed conditions.

Part 3 - Optional Regimen 1

VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation A

Intervention Type DRUG

Oral administration of VH4004280 Formulation A in fasted or fed conditions.

VH4004280 Formulation B

Intervention Type DRUG

Oral administration of VH4004280 Formulation B in fasted or fed conditions.

VH4004280 Formulation C

Intervention Type DRUG

Oral administration of VH4004280 Formulation C in fasted or fed conditions.

VH4004280 Formulation D

Intervention Type DRUG

Oral administration of VH4004280 Formulation D in fasted or fed conditions.

Part 3- Optional Regimen 2

VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation A

Intervention Type DRUG

Oral administration of VH4004280 Formulation A in fasted or fed conditions.

VH4004280 Formulation B

Intervention Type DRUG

Oral administration of VH4004280 Formulation B in fasted or fed conditions.

VH4004280 Formulation C

Intervention Type DRUG

Oral administration of VH4004280 Formulation C in fasted or fed conditions.

VH4004280 Formulation D

Intervention Type DRUG

Oral administration of VH4004280 Formulation D in fasted or fed conditions.

Part 3 - Optional Regimen 3

VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation A

Intervention Type DRUG

Oral administration of VH4004280 Formulation A in fasted or fed conditions.

VH4004280 Formulation B

Intervention Type DRUG

Oral administration of VH4004280 Formulation B in fasted or fed conditions.

VH4004280 Formulation C

Intervention Type DRUG

Oral administration of VH4004280 Formulation C in fasted or fed conditions.

VH4004280 Formulation D

Intervention Type DRUG

Oral administration of VH4004280 Formulation D in fasted or fed conditions.

Part 3 - Optional Regimen 4

VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions.

Group Type EXPERIMENTAL

VH4004280 Formulation A

Intervention Type DRUG

Oral administration of VH4004280 Formulation A in fasted or fed conditions.

VH4004280 Formulation B

Intervention Type DRUG

Oral administration of VH4004280 Formulation B in fasted or fed conditions.

VH4004280 Formulation C

Intervention Type DRUG

Oral administration of VH4004280 Formulation C in fasted or fed conditions.

VH4004280 Formulation D

Intervention Type DRUG

Oral administration of VH4004280 Formulation D in fasted or fed conditions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VH4004280 Formulation A

Oral administration of VH4004280 Formulation A in fasted or fed conditions.

Intervention Type DRUG

VH4004280 Formulation B

Oral administration of VH4004280 Formulation B in fasted or fed conditions.

Intervention Type DRUG

VH4004280 Formulation C

Oral administration of VH4004280 Formulation C in fasted or fed conditions.

Intervention Type DRUG

VH4004280 Formulation D

Oral administration of VH4004280 Formulation D in fasted or fed conditions.

Intervention Type DRUG

VH4004280 Formulation E

Oral administration of VH4004280 Formulation E in fasted or fed conditions.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participants must be 18 to 55years of age.
2. Participants who are overtly healthy.
3. Negative (Severe Acute Respiratory Syndrome Coronavirus 2) SARs-CoV-2 test prior to dosing.
4. Has body mass index (BMI) within the range 19-32 (kg/m2).
5. 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.
6. Capable of giving signed informed consent.

Exclusion Criteria

1. History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
2. Abnormal blood pressure.
3. Any malignancy within the past 5 years except certain localized malignancies, or breast cancer within the past 10 years.
4. Has exclusionary psychiatric, hepatic, cardiovascular, gastrointestinal, respiratory, endocrine, neurological, hematological, or renal condition.
5. Current or chronic history of liver disease or known hepatic or biliary abnormalities.
6. Participants with exclusionary electrocardiogram findings.
7. Past or intended use of exclusionary medications or vaccines.
8. Exposure \> 4 new investigational products within 12 months, previous participation in this study, or current enrolment or participation in another investigational study.
9. ALT \>1.5x upper limit of normal (ULN), total bilirubin \>1.5x ULN, and/or estimated serum creatinine clearance \<60 mL/min.
10. History of or current infection with hepatitis B or hepatitis C.
11. Positive SARS-CoV-2 test, having signs and symptoms suggestive of COVID-19, or contact with known COVID-19 positive person.
12. Positive HIV antibody test.
13. 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