The main objectives are: * To assess mass balance by determining the extent of recovery of total \[¹⁴C\]-radioactivity in urine and faeces after a single oral dose administration of BI 1815368 (C-14) (test treatment T) in healthy male trial participants. * To investigate the absolute bioavailability of BI 1815368 using a single, concomitant intravenous micro-dose administration of BI 1815368 (C13) (reference treatment R). * To provide plasma, urine, and faecal samples
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Unlabeled BI 1815368 mixed with \[C-14\]-labeled BI 1815368
\[13C\]-labeled BI 1815368
ICON-Groningen-62040
Groningen, Netherlands
Fraction of [14C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe urine,0-tz)
Time frame: Up to 24 days
Fraction of [14C]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe faeces,0-tz)
Time frame: Up to 24 days
Sum of fe urine,0-tz and fe faeces,0-tz (total recovery of [14C]-radioactivity)
Time frame: Up to 24 days
Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), after oral administration of BI 1815368 (C-14)
Time frame: Up to 24 days
AUC0-∞ of [13C]- BI 1815368, after a concomitant IV infusion of BI 1815368 (C-13)
Time frame: Up to 24 days
Maximum measured concentration of BI 1815368 in plasma (Cmax), after oral administration of BI 1815368 (C-14)
Time frame: Up to 24 days
Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point, after oral administration of BI 1815368 (C-14)
Time frame: Up to 24 days
Cmax of [14C]-radioactivity, after oral administration of BI 1815368 (C-14)
Time frame: Up to 24 days
AUC0-tz of [14C]-radioactivity, after oral administration of BI 1815368 (C-14)
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Time frame: Up to 24 days
Cmax of [13C]- BI 1815368
Time frame: Up to 24 days
AUC0-tz of [13C]- BI 1815368
Time frame: Up to 24 days