The main objectives of this trial are to investigate pharmacokinetics, safety and tolerability of BI 1015550 in Chinese healthy male and female subjects following administration of single doses.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
A single film-coated tablet BI 1015550 taken orally after an overnight fast of at least 10 hours.
Peking Union Medical College Hospital
Beijing, China
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
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 and 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 and 144 hours following drug administration.
Number of Subjects With Any Treatment-emergent Adverse Event (AE)
Number of subjects with any treatment-emergent adverse event (AE).
Time frame: Up to 7 days.
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