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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

NCT06168318 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-08-02

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections

Interventions

DRUG

VH4004280 Formulation A

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

DRUG

VH4004280 Formulation B

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

DRUG

VH4004280 Formulation C

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

DRUG

VH4004280 Formulation D

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

DRUG

VH4004280 Formulation E

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

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2024-06-03
Completion
2024-06-03
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06168318 on ClinicalTrials.gov