NCT01648257

Relative Bioavailability Study of GSK1265744 Formulations

A Single-center, Randomized, Open-label, Crossover Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8 days) and safety assessments will be performed. Each period will be separated by a washout period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose of study drug.

Conditions

• Infections, Human Immunodeficiency Virus and Hepatitis

Interventions

Type	Name	Description
DRUG	GSK1265744 Na Salt Tablets	Each tablet contains 30 mg of GSK1265744 sodium salt and excipients.
DRUG	GSK1265744 Free Acid Nanomilled Capsules	Each capsule contains 30 mg of nanomilled and spray dried GSK1265744 free acid, blended with excipients.
DRUG	GSK1265744 Free Acid Micronized Capsules	Each capsule contains 30 mg of micronized GSK1265744 free acid, blended with excipients.

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-07-24
• Last updated: 2016-08-12

Locations

1 site across 1 country: United States