The main objective of this trial is to investigate the relative bioavailability of BI 1015550 intended Commercial Formulation (iCF) compared with Trial Formulation 2 (TF2) and the effect of food on the pharmacokinetics of BI 1015550 iCF following oral administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Reference (R): three 6 milligram BI 1015550 film-coated tablets of Trial Formulation 2 (TF2) taken orally following an overnight fast of at least 10 hours.
Test treatment 1 (T1): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following an overnight fast of at least 10 hours.
Test treatment 2 (T2): one 18 milligram BI 1015550 film-coated tablet of the intended commercial formulation (iCF) taken orally following a high-calorie breakfast.
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Time frame: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours following drug administration.
Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of R-BI 1015550 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The endpoint was analyzed additionally for the chirally pure (R) form of BI 1015550 (R-BI 1015550, the pharmacologically active form).
Time frame: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours following drug administration.
Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
Maximum measured concentration of BI 1015550 in plasma (Cmax).
Time frame: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours following drug administration.
Maximum Measured Concentration of R-BI 1015550 in Plasma (Cmax)
Maximum measured concentration of R-BI 1015550 in plasma (Cmax). The endpoint was analyzed additionally for the chirally pure (R) form of BI 1015550 (R-BI 1015550, the pharmacologically active form).
Time frame: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours following drug administration.
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Predicted (AUC0-∞,Pred)
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Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity, predicted (AUC0-∞,pred).
Time frame: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours following drug administration.
Area Under the Concentration-time Curve of R-BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Predicted (AUC0-∞,Pred)
Area under the concentration-time curve of R-BI 1015550 in plasma over the time interval from 0 extrapolated to infinity, predicted (AUC0-∞,pred). The endpoint was analyzed additionally for the chirally pure (R) form of BI 1015550 (R-BI 1015550, the pharmacologically active form).
Time frame: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours following drug administration.