The primary objective of this trial is to investigate the relative bioavailability of BI 685509 given alone under fasted conditions (Reference, R) compared to the intake after a high fat, high caloric breakfast (Test 1, T1), to combined administration with itraconazole under fasted conditions (Test 2, T2) and to combined administration with rifampin under fasted conditions (Test 3, T3). The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments.
BI 685509 is a substrate of the drug transporters P-gp and Organic anion transporting polypeptide 1B1 and 1B3 (OATP1B1/OATP1B3). Inhibition of these transport proteins may result in an increased drug exposure which might impact the safety of the patients. Therefore this trial should investigate whether and to what extent the inhibition of P-gp (mediated by itraconazole) and the inhibition of OATP1B1/OATP1B3 (mediated by rifampin) affects kinetics of BI 685509. Itraconazole and rifampin are recommended probe drugs to test in-vivo inhibition of P-gp and OATP1B1/OATP1B3. Furthermore the food effect will be investigated in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
High-fat high calorie breakfast
Administration of itraconazole together with BI 685509
Administration of rifampicin together with BI 685509
Humanpharmakologisches Zentrum Biberach
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)
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)
Time frame: 4 Days
Cmax (maximum measured concentration of the analyte in plasma)
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 4 Days
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 4 Days
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BI 685509, given alone