The main objectives of the single rising doses (SRD) trial part are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy male subjects following administration of single rising doses. The main objective of the food effect part is to investigate the influence of food on the relative bioavailability of BI 1819479.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
BI 1819479
Placebo
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany
Percentage of subjects with drug-related adverse events
Single rising doses (SRD) part
Time frame: Up to Day 36
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Food effect part
Time frame: Up to Day 31
Maximum measured concentration of the analyte in plasma (Cmax)
Food effect part
Time frame: Up to Day 31
Maximum measured concentration of the analyte in plasma (Cmax)
SRD part
Time frame: Up to Day 31
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
SRD part
Time frame: Up to Day 31
Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity (AUC0-∞)
Food effect part
Time frame: Up to Day 31
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