drugset / Trial / NCT01031472

A Study to Assess Relative Bioavailability and Food Effect of New Formulations of GSK2248761

NCT01031472

Phase 1 Completed 24 enrolled ViiV Healthcare GlaxoSmithKline · collab
RandomizedCrossoverOpen-labelTreatment

Summary

This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the effect of up to three formulations on the relative bioavailability of GSK2248761 100mg administered with and without food. Part A will evaluate two new formulations compared to the current formulation. Part B will evaluate one additional formulation if the bioavailability of the two formulations in Part A do not meet pre-specified criteria. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-10 days after the last dose of study drug.

Timeline

Start
2009-12-21
Primary completion
2010-03-11
Completion
2010-03-11

Drugs

EvaluationDrugModalityDoseRoute
Subject FOSDEVIRINE Small molecule 100 mg