NCT05776108

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

A Phase 1, Single-center, Randomized, Open-label, Single Dose, Three-period, Balanced Crossover Study to Assess the Effect of Food on the Pediatric Dispersible Tablet Formulation of Cabotegravir and to Assess the Relative Bioavailability Between the Pediatric Dispersible Tablet (DT) Formulation and Immediate Release (IR) Tablet Formulation of Cabotegravir in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will assess the relative bioavailability of the CAB DT formulation relative to that of the CAB IR formulation and to assess the effect of food on the CAB DT formulation.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Cabotegravir IR Formulation (reference)	Cabotegravir IR Formulation (reference) will be administered.
DRUG	Cabotegravir DT Formulation (test 1)	Cabotegravir DT Formulation (test 1) will be administered.
DRUG	Cabotegravir DT Formulation (test 2)	Cabotegravir DT Formulation (test 2) will be administered.

Timeline

• Start date: 2023-03-23
• Primary completion: 2023-06-08
• Completion: 2023-06-08
• First posted: 2023-03-20
• Last updated: 2023-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study