Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
1293.8.8101 Boehringer Ingelheim Investigational Site
Sumida-ku,Tokyo, Japan
1293.8.8201 Boehringer Ingelheim Investigational Site
Seoul, South Korea
Number of Participants With Investigator Defined Drug-related Adverse Events
Number of participants with investigator defined drug-related adverse events (AEs) is reported.
Time frame: From study drug administration until end-of-study examination, up to 77 days.
Maximum Measured Concentration of BI 655064 in Plasma (Cmax)
Maximum measured concentration of BI 655064 in plasma (Cmax) is reported.
Time frame: Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.
Area Under the Concentration-time Curve of the Analyte BI 655064 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of the analyte BI 655064 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Time frame: Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.
Area Under the Concentration-time Curve of the Analyte BI 655064 in the Plasma Over the Time Interval From 0 to the Last Measurable Time Point (AUC0-tz)
Area under the concentration-time curve of the analyte BI 655064 in the plasma over the time interval from 0 to the last measurable time point (AUC0-tz) is reported.
Time frame: Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.
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