The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: midazolam (Drug); caffeine (Drug); digoxin (Drug); warfarin (Drug); omeprazole (Drug); BI 187004 (Drug); metoprolol (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
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.
Clinical Details
Official title: 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
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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 substratesCmax (Maximum measured concentration of the analyte in plasma) for probe substrates
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
1307.19.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
Additional Information
Starting date: October 2014
Last updated: December 19, 2014
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