NCT01754116

A Randomized Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 Long Acting Parental (LAP) in Healthy Adult Subjects

A Single-Center Randomized, Open-Label, Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 LAP in Healthy Adult Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, open-label, 3 parallel treatment study in healthy adult subjects to assess the relative bioavailability of new formulations of GSK1265744 LAP 400 mg intra muscular compared to the current GSK1265744 LAP 400 mg nanomilled formulation. This study will evaluate LAP formulations of GSK1265744 with different particle sizes. Following a 14 day lead in period with oral GSK1265744, forty-five subjects will receive 400 mg of one of three GSK1265744 formulations which vary in particle size from 200 nm to 5 um by intramuscular injection. Samples for determination of GSK1265744 concentrations will be collected for 12 weeks post-injection. Safety will be evaluated by adverse event recording and laboratory values at frequent intervals throughout the trial. A subgroup of 12 subjects will receive a 3 mg dose of oral midazolam at baseline on Day-29 and then again on the last day of the oral GSK1265744 lead in period to evaluate the effect of GSK1265744 on CYP3A enzymes. The subjects will undergo follow-up evaluations for a minimum of 12 weeks.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	GSK1265744 30 mg oral	GSK1265744B 30 mg Tablet taken orally, once a day in the morning with or without a meal
DRUG	Midazolam 3 mg oral + GSK1265744 30mg oral	Midazolam Syrup 3mg each mL Oral/single dose administer by oral syringe on Day -29 and Day -14
DRUG	GSK1265744 400 mg (200 nm)	A single dose of GSK1265744 400 mg Intra Muscular (IM) injection (Nanomilled 200 nm)
DRUG	GSK1265744 400 mg (1 micro m)	A single dose of GSK1265744 400 mg IM injection (Nanomilled 1 micrometer)
DRUG	GSK1265744 400 mg (5 micro m)	A single dose of GSK1265744 400 mg IM injection (Dry milling and homogenization 5 micrometer)

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-12-21
• Last updated: 2014-04-21

Locations

1 site across 1 country: United States