Effect of BI 1181181 on Midazolam, Warfarin, Omeprazole and 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: Omeprazole (Drug); Warfarin (Drug); BI 1181181 (Drug); Midazolam (Drug); Omeprazole (Drug); BI 1181181 (Drug); Midazolam (Drug); Midazolam (Drug); Warfarin (Drug); BI 1181181 (Drug); Digoxin (Drug); Digoxin (Drug)
Phase: Phase 1
Status: Withdrawn
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
Summary
To assess the influence of different dose strengths of BI 1181181 on single dose kinetics of
midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug)
and digoxin (P-gp probe drug)
Clinical Details
Official title: A Study to Investigate the Effects of BI 1181181 on the Pharmacokinetics of Midazolam, Warfarin, Omeprazole and Digoxin in Healthy Male Subjects
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover 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) of midazolam and omeprazol after each dosingAUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) of digoxin after each dosing 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) of warfarin after each dosing Cmax (Maximum measured concentration the analyte in plasma) of midazolam and omeprazol after each dosing Cmax (Maximum measured concentration the analyte in plasma) of digoxin after each dosing Cmax (Maximum measured concentration the analyte in plasma) of warfarin after each dosing
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
Criteria:
Inclusion criteria:
- healthy male subjects
- 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:
- Any finding in the medical examination (including BP, PR or ECG) is deviating from
normal and judged as clinically relevant by the investigator
- 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
Locations and Contacts
1344.3.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
Additional Information
Starting date: March 2015
Last updated: March 8, 2015
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