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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02345304

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Omeprazole Drug: Warfarin Drug: BI 1181181 Drug: Midazolam Drug: Omeprazole Drug: BI 1181181 Drug: Midazolam Drug: Midazolam Drug: Warfarin Drug: BI 1181181 Drug: Digoxin Drug: Digoxin	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Study to Investigate the Effects of BI 1181181 on the Pharmacokinetics of Midazolam, Warfarin, Omeprazole and Digoxin in Healthy Male Subjects

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2015

Anticipated Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment 3 single dose of midazolam + BI drug	Drug: Midazolam Drug: BI 1181181
Experimental: Treatment 4 single dose of probe drugs + BI drug	Drug: Omeprazole Drug: Midazolam Drug: BI 1181181 Drug: Warfarin
Experimental: Treatment 5 single dose of digoxin + BI drug	Drug: BI 1181181 Drug: Digoxin
Experimental: Treatment 1 single doses of probe drugs	Drug: Warfarin Drug: Omeprazole Drug: Midazolam
Experimental: Treatment 2 single dose of digoxin	Drug: Digoxin

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

healthy male subjects
age of 18 to 50 years
body mass index (BMI) of 18.5 to 29.9 kg/m2
Subjects must be able to understand and comply with study requirements

Exclusion criteria:

Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm at screening
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1344.3.1 Boehringer Ingelheim Investigational Site	Biberach		Germany

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT02345304

Other Study ID Numbers:

1344.3
2014-004329-42

First Posted:

Jan 26, 2015

Last Update Posted:

Mar 10, 2015

Last Verified:

Mar 1, 2015

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2015