A Study in Healthy Men to Test How BI 1358894 is Taken up and Handled by the Body

Mass balance and recoveries of \[14C\] BI 1358894 total radioactivity in urine and faeces after single oral dose as percentage of the administered dose over the time interval from 0 to tz, where tz is the latest quantifiable data point across all participants. Urine collection intervals were within 2 hours (h) predose, 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336 h after dosing on Day 1 and to be continued in 24 h intervals, on days 21-22, 28-29, 35-36, 42-43, and 49-50, if necessary. Faeces collection intervals were started from approximately -48 h before drug administration and 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336 h after dosing on Day 1 and to be continued in 24 h intervals, on days 21-22, 28-29, 35-36, 42-43, and 49-50, if necessary.

Time frame: From within 2 hours predose up to 50 days after dosing. For detailed time frames please refer to the intervals given under measure description above.

Population: Pharmacokinetic set (PKS) Part 1: This subject set included all subjects in treated set (TS) who provided at least one primary or secondary PK parameter that was not excluded according to description above. Thus, a subject was included in PKS, even if he/she contributed only one pharmacokinetics (PK) parameter value to the statistical assessment. Only subjects with available data were included in the analysis.

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) were determined for total \[14C\] BI 1358894 and non-radiolabeled BI 1358894 after single dose administration.

Time frame: At 2 hours (h) before first drug administration and at 20 minutes (min), 40min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h, 288h, 336h, 485h, 653h after first drug administration.

Population: Pharmacokinetic set (PKS) Part 1: This subject set included all subjects in the TS who provided at least one primary or secondary PK parameter that was not excluded according to the description above. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value to the statistical assessment.

Maximum measured concentration of the analyte in plasma (Cmax) determined for total \[14C\] BI 1358894 and non-radiolabeled BI 1358894 after single dose administration.

Time frame: At 2 hours (h) before first drug administration and at 20 minutes (min), 40min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h, 240h, 288h, 336h, 485h, 653h after first drug administration.

Population: Pharmacokinetic set (PKS): This subject set included all subjects in the TS who provided at least one primary or secondary PK parameter that was not excluded according to the description above. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value to the statistical assessment.

Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) was determined for non-radiolabeled BI 1358894. Tau = 24 hours.

Time frame: At 480h, 480.5h, 481h, 482h, 484h, 485h, 486h, 487h,488h, 490h, 492h, 494h and 504h after first drug administration.

Population: Pharmacokinetic set (PKS) Part 2: This subject set included all subjects in the TS who provided at least one primary or secondary PK parameter that was not excluded according to the description above. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value to the statistical assessment.

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours(AUC0-24) was determined for non-radiolabeled BI 1358894.

Time frame: At 2 hours (h) before first drug administration and at 30 minutes (min), 1h, 2h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h and 24h after first drug administration.

Population: Pharmacokinetic set (PKS) Part 2: This subject set included all subjects in the TS who provided at least one primary or secondary PK parameter that was not excluded according to the description above. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value to the statistical assessment.

Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss) was determined for non-radiolabeled BI 1358894. Tau = 24 hours.

Time frame: At 480h, 480.5h, 481h, 482h, 484h, 485h, 486h, 487h,488h, 490h, 492h, 494h and 504h after first drug administration.

Population: Pharmacokinetic set (PKS) Part 2: This subject set included all subjects in the TS who provided at least one primary or secondary PK parameter that was not excluded according to the description above. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value to the statistical assessment.

Maximum measured concentration of the analyte in plasma (Cmax) was determined for non-radiolabeled BI 1358894.

Time frame: At 2 hours (h) before first drug administration and at 30 minutes (min), 1h, 2h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h and 24h after first drug administration.

Population: Pharmacokinetic set (PKS): This subject set included all subjects in the TS who provided at least one primary or secondary PK parameter that was not excluded according to the description above. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value to the statistical assessment.