Single Rising Dose (SRD) part: The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 1584862 in healthy male subjects following oral administration of single rising doses. Food Effect (FE) part: The main objective of the FE part is to assess the influence of food on the relative bioavailability of the BI 1584862 tablet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
77
BI 1584862
Placebo
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
SRD-part:Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Time frame: Up to 14 days
FE-part: Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: Up to 6 days
FE-part: Maximum measured concentration of BI 1584862 in plasma (Cmax)
Time frame: Up to 6 days
SRD-Part: Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: Up to 6 days
SRD-Part: Maximum measured concentration of BI 1584862 in plasma (Cmax)
Time frame: Up to 6 days
FE-Part: Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 6 days
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