PK Interaction Between Rifapentine or Rifampicin and a Single Dose of TMC207 in Healthy Subjects (TMC207-CL002)
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
This is a open-label study, 2-treatment, 2-period, single sequence design. Period 1 will
examine the pharmacokinetics of TMC207 in the absence of rifapentine or rifampicin. Subjects
will receive a single 400-mg dose of TMC207 administered alone on Study Day 1. Period 2 will
examine the effects of repeated doses of either rifapentine or rifampicin on TMC207
pharmacokinetics and will begin on Study Day 20. During Period 2, subjects will receive 22
daily doses of either 600 mg rifapentine or rifampicin from Study Day 20 through Study Day
41. A single 400-mg dose of TMC207 will be administered on Study Day 29. Subjects will be
confined to the clinic from Study Day-1 to Study Day 2 in the morning of Period 1, and Study
Day 19 to Study Day 30 in the morning of Period 2. The study hypothesis is to determine
whether Rifapentine affects the pharmacokinetics of TMC207 as measured by effects on Cmax and
AUC(0-t) to a lesser degree than rifampicin.