drugset / Trial / NCT02256813
Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Warfarin, Omeprazole, Caffeine, and Dextromethorphan in Healthy Male Volunteers
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The study aimed to investigate the effect of BIRT 2584 XX and its metabolite BI 610100 on the Pharmacokinetics (PK) of five probe substrates for cytochrome P450 isozymes. The substrates used to monitor enzyme activity were oral warfarin (for CYP2C9), oral omeprazole (for CYP2C19), oral dextromethorphan (for CYP2D6), oral caffeine (for CYP1A2) and intravenous midazolam (for hepatic CYP3A)
Timeline
- Start
- 2005-09
- Primary completion
- 2005-12
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIRT 2584 XX | Unknown | 500 mg | — |
| Subject | Caffeine | Small molecule | — | Oral |
| Subject | Dextromethorphan | Unknown | — | Oral |
| Subject | Midazolam | Small molecule | — | Intravenous |
| Subject | Omeprazole | Other / unclassified | — | Oral |
| Subject | Warfarin | Small molecule | — | Oral |
| Background | Vitamin K | Unknown | — | — |
Indications
No indication recorded.