Effect of Rifampin (RIF) on the Pharmacokinetics (PK) of Oral Cabotegravir (CAB) in Healthy Subjects
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
CAB is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment
and prevention of human immunodeficiency virus-1 (HIV-1) infection. RIF, a rifamycin used for
treatment of tuberculosis (common co-infection in HIV-infected subjects), is a known inducer
of uridine diphosphate (UDP)-glucuronosyltransferases (UGTs) and Cytochrome P450 3A4
(CYP3A4). CAB is primarily metabolized via UGT1A1 and UGT1A9, thus a drug interaction between
CAB and RIF is possible. This study will be a phase I, single-center, open label,
fixed-sequence cross-over study to compare the single dose PK of CAB oral 30 milligrams (mg)
when co-administered with RIF 600 mg once daily at steady-state to those of CAB oral 30 mg
administered alone. Fifteen subjects are planned to be enrolled to obtain 12 evaluable
subjects for this study.