Effect of BI 1181181 on Midazolam, Warfarin, Omeprazole and Digoxin
NCT ID: NCT02345304
Last Updated: 2015-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2015-03-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Treatment 3
single dose of midazolam + BI drug
Midazolam
BI 1181181
Treatment 4
single dose of probe drugs + BI drug
Omeprazole
Midazolam
BI 1181181
Warfarin
Treatment 5
single dose of digoxin + BI drug
BI 1181181
Digoxin
Treatment 1
single doses of probe drugs
Warfarin
Omeprazole
Midazolam
Treatment 2
single dose of digoxin
Digoxin
Interventions
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Omeprazole
Warfarin
BI 1181181
Midazolam
Omeprazole
BI 1181181
Midazolam
Midazolam
Warfarin
BI 1181181
Digoxin
Digoxin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
MALE
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1344.3.1 Boehringer Ingelheim Investigational Site
Biberach, , Germany
Countries
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Other Identifiers
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2014-004329-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1344.3
Identifier Type: -
Identifier Source: org_study_id
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