To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy Chinese and Japanese male subjects following the administration of single rising oral doses and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809 after single dosing of product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
49
1346.4.82001 Boehringer Ingelheim Investigational Site
Busan, South Korea
Number of Subjects With Drug-Related Adverse Events (AEs)
This outcome measure presents the number of subjects with drug-related adverse events.
Time frame: Up to 11 days after drug administration.
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
This outcome measure presents maximum measured concentration of BI 425809 in plasma (Cmax).
Time frame: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Area Under the Concentration (AUC0-∞) Time Curve of BI 425809
This outcome measure presents area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Time frame: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Area Under the Concentration (AUC0-tz) Time Curve of BI 425809
This outcome measure presents area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the time of the last quantifiable plasma concentration (AUC0-tz).
Time frame: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
Tmax of BI 425809
This outcome measure presents time from dosing to the maximum concentration of BI 425809 in plasma (tmax).
Time frame: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.
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t1/2 of BI 425809
This outcome measure presents terminal half-life of BI 425809 in plasma (t1/2).
Time frame: -2.00 hours before drug administration and 0:30 (hours:minutes), 1:00, 2:00, 3:00, 3:30, 4:00, 4:30, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00 and 192:00 after drug administration.