Relative Bioavailability Study of Phase III Tablet Formulation of Cabotegravir
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design
in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt
tablet formulations relative to the current CAB sodium salt formulation being used in the
phase IIb studies under fasting conditions. All treatments will be administered as single 30
mg doses of CAB. 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. Treatment period doses will be separated by a 14 day washout. Participation in this
study will be approximately 12 weeks.