Effect of BI 1181181 on Midazolam, Warfarin, Omeprazole and Digoxin

Healthy Clinical Trial

Official title:

A Study to Investigate the Effects of BI 1181181 on the Pharmacokinetics of Midazolam, Warfarin, Omeprazole and Digoxin in Healthy Male Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02345304
• Other study ID #: 1344.3
• Secondary ID: 2014-004329-42
• Status: Withdrawn
• Phase: Phase 1
• First received: January 20, 2015
• Last updated: March 8, 2015
• Start date: March 2015
• Est. completion date: May 2015

Study information

• Verified date: March 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Omeprazole

• Warfarin

• BI 1181181

• Midazolam

• Omeprazole

• BI 1181181

• Midazolam

• Midazolam

• Warfarin

• BI 1181181

• Digoxin

• Digoxin

Locations

Country	Name	City	State
Germany	1344.3.1 Boehringer Ingelheim Investigational Site	Biberach

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		up to 24 hours	No
Primary	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		up to 96 hours	No
Primary	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		up to 120 hours	No
Primary	Cmax (Maximum measured concentration the analyte in plasma) of midazolam and omeprazol after each dosing		up to 24 hours	No
Primary	Cmax (Maximum measured concentration the analyte in plasma) of digoxin after each dosing		up to 96 hours	No
Primary	Cmax (Maximum measured concentration the analyte in plasma) of warfarin after each dosing		up to 120 hours	No