NCT02345707

Relative Bioavailability Study of Phase III Tablet Formulation of Cabotegravir

A Phase 1, Single-center, Randomized, Open-label, Crossover Study to Assess the Relative Bioavailability of Phase III Tablet Formulation Candidates in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt tablet formulations relative to the current CAB sodium salt formulation being used in the phase IIb studies under fasting conditions. All treatments will be administered as single 30 mg doses of CAB. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study drug. Treatment period doses will be separated by a 14 day washout. Participation in this study will be approximately 12 weeks.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Cabotegravir 30 mg current formulation	Cabotegravir 30 mg current formulation (Treatment A) is a film coated tablet with a weight of 824 mg
DRUG	Cabotegravir 30 mg micronized new formulation 500 M	Cabotegravir 30 mg micronized new formulation 500 M (Treatment B) is a film coated tablet with a weight of 515 mg
DRUG	Cabotegravir 30 mg unmicronized new formulation 500 U	Cabotegravir 30 mg unmicronized new formulation 500 U (Treatment C) is a film coated tablet with a weight of 515 mg
DRUG	Cabotegravir 30 mg micronized new formulation 650 M	Cabotegravir 30 mg micronized new formulation 650 M (Treatment D) is a film coated tablet with a weight of 670 mg
DRUG	Cabotegravir 30 mg unmicronized new formulation 650 U	Cabotegravir 30 mg unmicronized new formulation 650 U (Treatment E) is a film coated tablet with a weight of 670 mg

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-01-26
• Last updated: 2015-07-13

Locations

1 site across 1 country: United States