The goal of this study is to find out how BI 1584862 moves through and exits the body of healthy men. To do this, BI 1584862 is labelled using radioactive carbon (C-14) and using a non-radioactive, naturally occurring, stable isotope (C-13). The study will measure how much of the study medicine is recovered in urine and faeces after taking it by mouth. It will also look at how much of the study medicine enters the bloodstream when taken by mouth compared to a small dose given directly into the bloodstream. The study staff measures the amount of BI 1584862 and its broken-down parts in the blood, the urine, and the stool.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
\[13C\]-labeled BI 1584862, Reference treatment
BI 1584862 (C-14), Test treatment
ICON-Groningen-62040
Groningen, Netherlands
RECRUITINGFraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine,0-tz)
hADME part
Time frame: Up to Day 14
Fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces,0-tz)
hADME part
Time frame: Up to Day 14
Sum of feurine,0-tz and fefaeces,0-tz (total recovery of [14C]-radioactivity)
hADME part
Time frame: Up to Day 14
Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14) (AUC0-∞)
BA part
Time frame: Up to day 13
Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of [13C]-BI 1584862 after a single intravenous infusion of BI 1584862 (C-13) (AUC0-∞)
BA part
Time frame: Up to Day 6
Cmax (maximum measured concentration of the analyte in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14)
hADME and BA part
Time frame: Up to Day 13
AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14)
hADME and BA part
Time frame: Up to Day 13
Cmax of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14)
hADME part
Time frame: Up to Day 13
AUC0-tz of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14)
hADME part
Time frame: Up to Day 13
Cmax of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13)
BA part
Time frame: Up to Day 6
AUC0-tz of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13)
BA part
Time frame: Up to Day 6
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