A Study to Assess The Relative Bioavailability of New Tablet Formulations of GSK1265744 in Healthy Adult Subjects
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
This study will evaluate two new GSK1265744 sodium salt tablet formulations and provide data
for selection of one of these tablet formulations for use in Phase 3. This is a
single-center, randomized, two part, open-label, crossover study in healthy adult subjects.
Part A is a randomized, open-label, 3-way balanced cross-over design in 24 subjects to assess
the oral bioavailability of two GSK1265744 sodium salt tablet formulations relative to the
current GSK1265744 sodium salt formulation being used in the phase IIb studies under fasting
conditions. Part A treatment periods will be separated by a 14 day washout. After completion
of Part A, preliminary PK data will be analyzed and a decision will be made based on
pre-specified criteria, as to which formulation will be used to conduct Part B. Fifteen
subjects who will have participated in Part A will participate in Part B and receive the
selected formulation with a moderate fat meal. All treatments will be administered as single
30 mg doses of GSK1265744. 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.