NCT01098513

GSK1349572 Relative Bioavailability Study

Relative Bioavailability Study of Three Different Tablet Formulations of GSK1349572 50 mg and the Dose Proportionality of and Effect of Food on the Selected Formulation in Healthy Male and Female Volunteers (ING113674)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects. Part A will evaluate the relative bioavailability of two new tablet formulations compared to the current tablet formulation of GSK1349572 at 50 mg administered as single doses each comprising of two 25 mg tablets. Pharmacokinetic samples from Part A will be analyzed and, if at least one of the new formulations meets appropriate criteria and is selected, Part B will be a single-sequence design conducted to evaluate food effect of the selected new tablet formulation at one dose level. A subset of subjects enrolled in Part A will continue in Part B. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-28 days after the last dose of study drug.

Detailed description

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	GSK1349572 formulation AP	GSK1349572 50 mg single dose fasted.
DRUG	GSK1349572 formulation AW	GSK1349572 formulation AW 50 mg single dose in Part A and 75 to 200 mg fasted or with moderate or high fat meal in Part B.
DRUG	GSK1349572 formulation AX	GSK1349572 formulation AX 50 mg in Part A and 75-200 mg fasted or with a moderate or high fat meal in Part B

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2010-04-02
• Last updated: 2017-06-09

Locations

1 site across 1 country: United States