Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Midazolam; Drug: Digoxin; Drug: BI 425809; Drug: Warfarin; Drug: Omeprazole

• Registration Number: NCT02783040
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To assess the influence of multiple doses of BI 425809 on single dose pharmacokinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2016-03-23
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-23
• Last Update Submitted: 2016-05-23
• Study First Posted: 2016-05-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
single dose cocktail (Midazolam, Warfarin, Omeprazole)	Midazolam	-
single dose cocktail (Midazolam, Warfarin, Omeprazole)	Warfarin	-
single dose Digoxin	Digoxin	-
multiple dose BI 425809	BI 425809	-
single dose cocktail (Midazolam, Warfarin, Omeprazole)	Omeprazole	-
single dose Midazolam	Midazolam	-

Primary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of the analyte in plasma)	0-119 hours
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)	0-119 hours

Trial Locations

Locations (1)

1346.22.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany