Overview

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

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:

Participant gender:

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)

Phase:

Phase 1

Details

Lead Sponsor:

Boehringer Ingelheim

Treatments:

Caffeine
Dextromethorphan
Midazolam
Omeprazole
Vitamin K
Vitamin K 1
Warfarin