Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The objective of this trial was to quantify the effect of oral single-dose (480 mg) and
steady-state BI 201335 NA (240 mg BID) on intestinal and hepatic cytochrome P450 (CYP) and
P-glycoprotein (P-gp) probe drugs as a means of predicting drug interactions. The AUCs for
the probe drugs caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin were
assessed.
Phase:
Phase 1
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Caffeine Dextromethorphan Digoxin Krestin Midazolam Omeprazole Vitamin K Warfarin