drugset / Trial / NCT02182336
Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2008-06
- Primary completion
- 2008-09
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | — | — |
| Subject | Dextromethorphan | Unknown | — | — |
| Subject | Digoxin | Other / unclassified | — | — |
| Subject | Faldaprevir | Small molecule | 240 mg | Oral |
| Subject | Midazolam | Small molecule | — | Oral |
| Subject | Omeprazole | Other / unclassified | — | — |
| Subject | Warfarin | Small molecule | — | — |
| Background | Vitamin K | Unknown | — | — |
Indications
No indication recorded.