To assess the influence of risankizumab on kinetics of cytochrome P450 (CYP) probe drugs as a means of predicting drug-drug interactions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Boehringer Ingelheim Investigational Site
Berlin, Germany
AUC0 - tz (area under the concentration-time curve) of caffeine with risankizumab in plasma over time interval from 0 to last quantifiable data point
Time frame: Day 98-101
AUC0 - tz (area under the concentration-time curve) of caffeine without risankizumab in plasma over time interval from 0 to last quantifiable data point
Time frame: Day 1-3
AUC0 - tz (area under the concentration-time curve) of warfarin with risankizumab in plasma over time interval from 0 to last quantifiable data point
Time frame: Day 98 - 105
AUC0 - tz (area under the concentration-time curve) of warfarin without risankizumab in plasma over time interval from 0 to last quantifiable data point
Time frame: Day 1-8
AUC0 - tz (area under the concentration-time curve) of omeprazole with risankizumab in plasma over time interval from 0 to last quantifiable data point
Time frame: Day 98 - 100
AUC0 - tz (area under the concentration-time curve) of omeprazole without risankizumab in plasma over time interval from 0 to last quantifiable data point
Time frame: Day 1-2
AUC0 - tz (area under the concentration-time curve) of metoprolol with risankizumab in plasma over time interval from 0 to last quantifiable data point
Time frame: Day 98 -100
AUC0 - tz (area under the concentration-time curve) of metoprolol without risankizumab in plasma over time interval from 0 to last quantifiable data point
Time frame: Day 1-3
AUC0 - tz (area under the concentration-time curve) of midazolam with risankizumab in plasma over time interval from 0 to last quantifiable data point
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Time frame: Day 98 - 99
AUC0 - tz (area under the concentration-time curve) of midazolam without risankizumab in plasma over time interval from 0 to last quantifiable data point
Time frame: Day 1-2
Cmax (maximum measured concentration) of the analyte omeprazole without risankizumab in plasma
Time frame: Day 1
Cmax (maximum measured concentration) of the analyte metoprolol with risankizumab in plasma
Time frame: Day 98
Cmax (maximum measured concentration) of the analyte metoprolol without risankizumab in plasma
Time frame: Day 1
Cmax (maximum measured concentration) of the analyte midazolam with risankizumab in plasma
Time frame: Day 98
Cmax (maximum measured concentration) of the analyte midazolam without risankizumab in plasma
Time frame: Day 1
Cmax (maximum measured concentration) of the analyte caffeine with risankizumab in plasma
Time frame: Day 98
Cmax (maximum measured concentration) of the analyte caffeine without risankizumab in plasma
Time frame: Day 1
Cmax (maximum measured concentration) of the analyte warfarin with risankizumab in plasma
Time frame: Day 98
Cmax (maximum measured concentration) of the analyte warfarin without risankizumab in plasma
Time frame: Day 1
Cmax (maximum measured concentration) of the analyte omeprazole with risankizumab in plasma
Time frame: Day 98