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

The Effect of Multiple Doses of BI 187004 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P-glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02254148

Enrollment

Registered

2014-10-01

Start date

2014-10-31

Completion date

2014-12-31

Last updated

2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGmidazolam

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

DRUGcaffeine

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

DRUGdigoxin

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

DRUGwarfarin

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

DRUGomeprazole

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

DRUGBI 187004

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

DRUGmetoprolol

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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) for probe substrates	up to 143 hours postdose
Cmax (Maximum measured concentration of the analyte in plasma) for probe substrates	up to 143 hours postdose

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026