This trial is conducted in healthy male subjects to evaluate the drug BI 1839100. The trial has two main parts. Part A aims to understand how BI 1839100 is processed in the body after an oral dose. It measures the total recovery of the drug and its radioactive label in urine and feces. It also determines the concentrations in blood plasma and investigates the drug's metabolic pathways. Part B aims to compare the absolute bioavailability of BI 1839100 when administered orally and intravenously.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
ICON-Groningen-62040
Groningen, Netherlands
Mass balance and total recovery of [C-14]-radioactivity in urine and feces.
Part A
Time frame: From drug administration up to Day 21.
Area under the concentration-time curve of Carbon-14-labeled BI 1839100 after intravenous administration and BI 1839100 after oral administration, extrapolated to infinity (AUC0-∞).
Part B
Time frame: From drug administration up to Day 21.
Maximum measured concentration of BI 1839100 and Carbon-14-labeled BI 1839100 in plasma (Cmax).
Part A
Time frame: Two hours before drug administration up to Day 21.
Area under the concentration-time curve of BI 1839100 and Carbon-14-labeled BI 1839100 from 0 to the last quantifiable time point (AUC0-tz).
Part A
Time frame: Two hours before drug administration up to Day 21.
Area under the concentration-time curve of Carbon-14-labeled BI 1839100 in plasma after intravenous administration and BI 1839100 after oral administration, from 0 to the last quantifiable time point (AUC0-tz).
Part B
Time frame: Two hours before drug administration up to 72 hours (Day 4).
Maximum measured concentration of Carbon-14-labeled BI 1839100 in plasma after intravenous administration and BI 1839100 after oral administration (Cmax).
Part B
Time frame: Two hours before drug administration up to 72 hours (Day 4).
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