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

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: VH4004280 Formulation A; Drug: VH4004280 Formulation D; Drug: VH4004280 Formulation E; Drug: VH4004280 Formulation B; Drug: VH4004280 Formulation C

Study type: Interventional

Funder types: Industry

Identifiers

NCT06168318

220095

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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46 participants in 13 patient groups

Part 1 - Regimen A

Experimental group

Description:

VH4004280 Formulation A tablet administered in fed conditions.

Treatment:

Drug: VH4004280 Formulation A

Part 1 - Regimen B

Experimental group

Description:

VH4004280 Formulation B tablet administered in fed conditions.

Treatment:

Drug: VH4004280 Formulation B

Part 1 - Regimen C

Experimental group

Description:

VH4004280 Formulation C tablet administered in fed conditions.

Treatment:

Drug: VH4004280 Formulation C

Part 1 - Optional Regimen D

Experimental group

Description:

VH4004280 Formulation D tablet administered in fed conditions.

Treatment:

Drug: VH4004280 Formulation D

Part 1 - Optional Regimen E

Experimental group

Description:

VH4004280 Formulation E tablet administered in fed conditions.

Treatment:

Drug: VH4004280 Formulation E

Part 2 - Regimen A

Experimental group

Description:

VH4004280 Formulation A tablet administered in fasted conditions.

Treatment:

Drug: VH4004280 Formulation A

Part 2- Optional Regimen 1

Experimental group

Description:

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

Treatment:

Drug: VH4004280 Formulation C

Drug: VH4004280 Formulation B

Drug: VH4004280 Formulation E

Drug: VH4004280 Formulation D

Part 2- Optional Regimen 2

Experimental group

Description:

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

Treatment:

Drug: VH4004280 Formulation C

Drug: VH4004280 Formulation B

Drug: VH4004280 Formulation E

Drug: VH4004280 Formulation D

Part 2- Optional Regimen 3

Experimental group

Description:

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

Treatment:

Drug: VH4004280 Formulation C

Drug: VH4004280 Formulation B

Drug: VH4004280 Formulation E

Drug: VH4004280 Formulation D

Part 3 - Optional Regimen 1

Experimental group

Description:

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

Treatment:

Drug: VH4004280 Formulation C

Drug: VH4004280 Formulation B

Drug: VH4004280 Formulation D

Drug: VH4004280 Formulation A

Part 3- Optional Regimen 2

Experimental group

Description:

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

Treatment:

Drug: VH4004280 Formulation C

Drug: VH4004280 Formulation B

Drug: VH4004280 Formulation D

Drug: VH4004280 Formulation A

Part 3 - Optional Regimen 3

Experimental group

Description:

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

Treatment:

Drug: VH4004280 Formulation C

Drug: VH4004280 Formulation B

Drug: VH4004280 Formulation D

Drug: VH4004280 Formulation A

Part 3 - Optional Regimen 4

Experimental group

Description:

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

Treatment:

Drug: VH4004280 Formulation C

Drug: VH4004280 Formulation B

Drug: VH4004280 Formulation D

Drug: VH4004280 Formulation A