The main objectives of this trial are: To assess the mass balance (total recovery of \[14C\]-radioactivity) in urine, faeces, and expired air after a single subcutaneous dose of BI 3034701 (C-14) in healthy male trial participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
BI 3034701 mixed with \[C-14\]BI 3034701
Pharmaceutical Research Associates Magyarorszag
Budapest, Hungary
RECRUITINGFraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine, 0-tz)
Time frame: Up to Day 50.
Fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces, 0-tz)
Time frame: Up to Day 50.
Fraction of [14C]-radioactivity excreted in expired air expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feexpired air, 0-tz)
Time frame: Up to Day 49.
Sum of feurine, 0-tz, fefaeces, 0-tz and feexpired air, 0-tz
Time frame: Up to Day 50.
Maximum measured concentration of [14C]-radioactivity in plasma
Time frame: Up to Day 22.
Maximum measured concentration of BI 3034701 in plasma
Time frame: Up to Day 22.
Area under the concentration-time curve of [14C]-radioactivity in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)
Time frame: Up to Day 22.
Area under the concentration-time curve of BI3034701 in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)
Time frame: Up to Day 22.
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