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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 187004; Drug: midazolam; Drug: omeprazole; Drug: digoxin; Drug: warfarin; Drug: caffeine; Drug: metoprolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02254148

1307.19

2013-005029-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Drug: warfarin

Drug: BI 187004

Drug: midazolam

Drug: caffeine

Drug: digoxin

Drug: omeprazole

Drug: metoprolol