Overview

This trial is active, not recruiting.

Condition healthy
Treatments midazolam, caffeine, digoxin, warfarin, omeprazole, bi 187004, metoprolol
Phase phase 1
Sponsor Boehringer Ingelheim
Start date October 2014
End date November 2014
Trial size 24 participants
Trial identifier NCT02254148, 1307.19, 2013-005029-22

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004
midazolam
single dose of midazolam given as oral solution (day 1 of visits 2 and 3)
caffeine
single dose of caffeine given as tablets (day 1 of visits 2 and 3)
digoxin
single dose of digoxin given as tablets (day 3 of visits 2 and 3)
warfarin
single dose of warfarin given as tablets (day 1 of visits 2 and 3)
omeprazole
single dose of omeprazole given as tablet (day 1 of visits 2 and 3)
bi 187004
multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3)
metoprolol
single dose of metoprolol given as tablets (day 1 of visits 2 and 3)

Primary Outcomes

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

Eligibility Criteria

Male participants from 18 years up to 55 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.