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The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)

NCT ID: NCT02254148

Last Updated: 2014-12-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-12-31

Brief Summary

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To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein (P-gp) probe drugs as a means of predicting drug-drug interactions.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004

Group Type EXPERIMENTAL

midazolam

Intervention Type DRUG

single dose of midazolam given as oral solution (day 1 of visits 2 and 3)

caffeine

Intervention Type DRUG

single dose of caffeine given as tablets (day 1 of visits 2 and 3)

digoxin

Intervention Type DRUG

single dose of digoxin given as tablets (day 3 of visits 2 and 3)

warfarin

Intervention Type DRUG

single dose of warfarin given as tablets (day 1 of visits 2 and 3)

omeprazole

Intervention Type DRUG

single dose of omeprazole given as tablet (day 1 of visits 2 and 3)

BI 187004

Intervention Type DRUG

multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3)

metoprolol

Intervention Type DRUG

single dose of metoprolol given as tablets (day 1 of visits 2 and 3)

Interventions

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midazolam

single dose of midazolam given as oral solution (day 1 of visits 2 and 3)

Intervention Type DRUG

caffeine

single dose of caffeine given as tablets (day 1 of visits 2 and 3)

Intervention Type DRUG

digoxin

single dose of digoxin given as tablets (day 3 of visits 2 and 3)

Intervention Type DRUG

warfarin

single dose of warfarin given as tablets (day 1 of visits 2 and 3)

Intervention Type DRUG

omeprazole

single dose of omeprazole given as tablet (day 1 of visits 2 and 3)

Intervention Type DRUG

BI 187004

multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3)

Intervention Type DRUG

metoprolol

single dose of metoprolol given as tablets (day 1 of visits 2 and 3)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. healthy male subjects
2. age of 18 to 55 years
3. body mass index of 18.5 to 29.9 kg/m2
4. Subjects must be able to understand and comply with study requirements

Exclusion Criteria

1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. 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
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1307.19.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2013-005029-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1307.19

Identifier Type: -

Identifier Source: org_study_id