NCT06168318

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

A 3-part, Phase 1, Single-center, Open-label Study to Assess the Relative Bioavailability of Oral Formulations for an Investigational Capsid Inhibitor in Healthy Adult Participants, and to Evaluate the Effect of Food on Bioavailability for an Investigational Capsid Inhibitor in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-12-18
• Primary completion: 2024-06-03
• Completion: 2024-06-03
• First posted: 2023-12-13
• Last updated: 2024-08-02

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study