This trial is intended to investigate the mass balance, metabolism, and basic pharmacokinetics of BI 1819479 (C-14) (Part A) and to investigate the absolute bioavailability of BI 1819479 (Part B) in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Quotient Sciences
Nottingham, United Kingdom
Part A: 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 37 days.
Part A: 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 faeces, 0-tz)
Time frame: Up to 37 days.
Part B: area under the concentration-time curve of [14C]BI 1819479 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: Up to 31 days.
Part A: Maximum measured concentration of [14C]BI 1819479-EQ in plasma (Cmax)
Time frame: Up to 36 days.
Part A: Area under the concentration-time curve of [14C]BI 1819479-EQ in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
Time frame: Up to 36 days.
Part B: Maximum measured concentration of [14C]BI 1819479 in plasma (Cmax)
Time frame: Up to 31 days.
Part B: Maximum measured concentration of BI 1819479 in plasma (Cmax)
Time frame: Up to 31 days.
Part B: Area under the concentration-time curve of [14C]BI 1819479 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
Time frame: Up to 31 days.
Part B: Area under the concentration-time curve of BI 1819479 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)
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Time frame: Up to 31 days.