Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects
Status:
Completed
Trial end date:
2017-09-07
Target enrollment:
Participant gender:
Summary
This is a Phase I, single-center, open-label, fixed-sequence, 2-period crossover study in
healthy adults to evaluate the effect of oral rifabutin (RBT) 300 milligram (mg) on the
pharmacokinetics of oral cabotegravir (CAB) 30 milligram ( mg). This study will evaluate the
drug-drug interaction (DDI) potential between CAB and RBT to inform dosing strategies for
tuberculosis in subjects receiving CAB for human immunodeficiency virus (HIV) treatment or
prevention. In Treatment Period 1 (Treatment A) participants will receive CAB 30 mg once
daily for 14 days, followed by Treatment Period 2 (Treatment B) where participants will
receive RBT 300 mg once daily with CAB 30 mg once daily for 14 days. The total study duration
will be approximately for 10 weeks. Approximately 15 healthy subjects will be enrolled to
ensure that 12 subjects complete dosing and critical assessments.