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 1815368 in healthy male subjects following oral administration of single rising doses. Bioavailability (BA) part The main objective of the BA part is to investigate the relative bioavailability of a tablet formulation versus oral solution and to assess the influence of food on the relative bioavailability of the tablet formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
Humanpharmakologisches Zentrum Biberach
Biberach, Germany
SRD part: Occurrence of any treatment-emergent adverse event
Time frame: Up to Day 14
BA part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: Up to Day 5
BA part: Maximum measured concentration of BI 1815368 in plasma (Cmax)
Time frame: Up to Day 5
SRD part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time frame: up to Day 6
SRD part: Maximum measured concentration of BI 1815368 in plasma (Cmax)
Time frame: up to Day 6
BA part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to Day 5
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