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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
1307.19.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
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
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single dose of warfarin given as tablets (day 1 of visits 2 and 3)
single dose of omeprazole given as tablet (day 1 of visits 2 and 3)
multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3)
single dose of metoprolol given as tablets (day 1 of visits 2 and 3)