The main objectives of this trial are: * To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T). * To investigate the absolute bioavailability of BI 1569912 as single oral solution dose, using a single, concomitant intravenous micro-tracer administration of BI 1569912 (C-13) (reference treatment, R)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
unlabelled BI 1569912 mixed with \[14C\]- labelled BI 1569912
\[13C\]- labelled BI 1569912
ICON-Groningen-62040
Groningen, Netherlands
Mass balance recovery for [ 14 C]- radioactivity in urine after oral administration of BI 1569912 (C-14): fe urine,0-tz (fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)
Time frame: up to Day 14.
Mass balance recovery for [ 14 C]- radioactivity in faeces after administration of BI 1569912 (C-14): fe faeces,0-tz (fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)
Time frame: up to Day 14.
Mass balance recovery for [14C]- radioactivity in urine and faeces after oral administration of BI 1569912 (C-14): Sum of feurine,0-tz and fefaeces,0-tz (total recovery of [14C]-radioactivity)
Time frame: up to Day 14.
AUC0-∞ (area under the concentration-time curve over the time interval from 0 extrapolated to infinity in plasma) of BI 1569912 after a single oral administration of BI 1569912 (C-14)
Time frame: up to Day 13.
AUC0-∞ (area under the concentration-time curve over the time interval from 0 extrapolated to infinity in plasma) of [ 13 C] BI 1569912 after a single intravenous infusion of BI 1569912 (C-13)
Time frame: up to Day 6.
Cmax (maximum measured concentration in plasma) of BI 1569912 after a single oral administration of BI 1569912 (C-14)
Time frame: up to Day 13.
AUC0-tz (area under the concentration-time curve over the time interval from 0 to the last quantifiable time point in plasma) of BI 1569912 after a single oral administration of BI 1569912 (C-14)
Time frame: up to Day 13.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cmax (maximum measured concentration in plasma) of [ 14 C]-radioactivity after a single oral administration of BI 1569912 (C-14)
Time frame: up to Day 13.
AUC0-tz (area under the concentration-time curve over the time interval from 0 to the last quantifiable time point in plasma) of [ 14 C]-radioactivity after a single oral administration of BI 1569912 (C-14)
Time frame: up to Day 13.
Cmax of [ 13 C] BI 1569912 after a single intravenous administration of BI 1569912 (C- 13)
Time frame: up to Day 6.
AUC0-tz of [ 13 C] BI 1569912 after a single intravenous administration of BI 1569912 (C-13)
Time frame: up to Day 6.