Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Single-Center Randomized, Open-Label, Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 LAP in Healthy Adult Subjects.
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.
n/a
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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