The objective of the single rising dose part (SRD) is to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male subjects. The objective of the food effect part (FE) is to investigate the relative bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
1333.1.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Number of subjects with drug- related adverse events.
Time frame: up to 2 weeks
Cmax (maximum measured concentration of BI 1060469 in plasma)
Time frame: up to 2 weeks
AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 2 weeks
AUC0-tz (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 up to the last quantifiable data point)
Time frame: up to 2 weeks
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