Effect of BI 1181181 on Midazolam, Warfarin, Omeprazole and Digoxin

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: Omeprazole; Drug: Midazolam; Drug: Warfarin; Drug: Digoxin; Drug: BI 1181181

• Registration Number: NCT02345304
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To assess the influence of different dose strengths of BI 1181181 on single dose kinetics 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 First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-20
• Study First Posted: 2015-01-26
• Status Verified: 2015-03
• Study Start: 2015-03
• Last Update Submitted: 2015-03-08
• Last Update Posted: 2015-03-10
• Primary Completion: 2015-04
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment 4	Omeprazole	single dose of probe drugs + BI drug
Treatment 4	BI 1181181	single dose of probe drugs + BI drug
Treatment 5	BI 1181181	single dose of digoxin + BI drug
Treatment 3	Midazolam	single dose of midazolam + BI drug
Treatment 3	BI 1181181	single dose of midazolam + BI drug
Treatment 4	Midazolam	single dose of probe drugs + BI drug
Treatment 1	Omeprazole	single doses of probe drugs
Treatment 1	Warfarin	single doses of probe drugs
Treatment 4	Warfarin	single dose of probe drugs + BI drug
Treatment 5	Digoxin	single dose of digoxin + BI drug
Treatment 1	Midazolam	single doses of probe drugs
Treatment 2	Digoxin	single dose of digoxin

Primary Outcome Measures

Name	Time	Method
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) of midazolam and omeprazol after each dosing	up to 24 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) of digoxin after each dosing	up to 96 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) of warfarin after each dosing	up to 120 hours
Cmax (Maximum measured concentration the analyte in plasma) of midazolam and omeprazol after each dosing	up to 24 hours
Cmax (Maximum measured concentration the analyte in plasma) of digoxin after each dosing	up to 96 hours
Cmax (Maximum measured concentration the analyte in plasma) of warfarin after each dosing	up to 120 hours

Trial Locations

Locations (1)

1344.3.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany