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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Status: Withdrawn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 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 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

Page last updated: August 23, 2015

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