Adults 18 to 65, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of the Amount of [14C]-Radioactivity Excreted Among the Administered Single Oral Dose of [14-C] BI 1015550-EQ in Urine (Feurine, 0-tz), Faeces (Fefaeces, 0-tz) and Vomit (Fevomit, 0-tz)Primary· From Day -1 or Day 1 - 2 hours (h) before drug administration until release criteria for radioactivity recovery had been met, up to Day 30-31. See also description section.
0-tz refers to 0 until latest individually available cumulative fraction after drug administration.
Vomit=Not applicable. Amount excreted calculated by volume multiplied with concentration of sample for respective time interval. Amount then refers to administered dose as fraction excreted in percent (dose=100%), done cumulatively.
Time frames:
Urine: on Day -1 or 1 -2 hours (h) before drug administration + at 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216 h after drug administration.
Faeces: on Day -1 or 1 -2 hours (h) before drug administration + 0-
urine
Group
Value
95% CI
BI 1015550 (C-14)
36.4
± 11.8
faeces
Group
Value
95% CI
BI 1015550 (C-14)
58.0
± 12.7
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)Secondary· Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
Group
Value
95% CI
BI 1015550 (C-14)
2850
± 19.5
Area Under the Concentration-time Curve of BI 764333 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)Secondary· Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Area under the concentration-time curve of BI 764333 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
BI 764333 is a metabolite of BI 1015550.
Group
Value
95% CI
BI 1015550 (C-14)
672
± 32.9
Area Under the Concentration-time Curve of [14-C] BI 1015550-EQ in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)Secondary· Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Area under the concentration-time curve of \[14-C\] BI 1015550-EQ in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
Group
Value
95% CI
BI 1015550 (C-14)
10600
± 25.6
Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)Secondary· Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Maximum measured concentration of BI 1015550 in plasma (Cmax) is presented.
Group
Value
95% CI
BI 1015550 (C-14)
544
± 11.8
Maximum Measured Concentration of BI 764333 in Plasma (Cmax)Secondary· Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Maximum measured concentration of BI 764333 in plasma (Cmax) is presented. BI 764333 is a metabolite of BI 1015550.
Group
Value
95% CI
BI 1015550 (C-14)
13.0
± 29.2
Maximum Measured Concentration of [14-C] BI 1015550-EQ in Plasma (Cmax)Secondary· Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Maximum measured concentration of \[14-C\] BI 1015550-EQ in plasma (Cmax) is presented.
Group
Value
95% CI
BI 1015550 (C-14)
606
± 12.4
Percentage of Participants With Treatment-emergent Adverse Events (TEAE)Secondary· From the first administration of the trial drug until end of the trial, up to 31 days.
Percentage of participants with treatment-emergent adverse events (TEAE) is presented.
Percentages were rounded to one decimal place.
Group
Value
95% CI
BI 1015550 (C-14)
66.7
Adverse events — posted to ClinicalTrials.gov
Time frame: "All-Cause Mortality", "Serious Adverse Events", and "Other Adverse Events": From the first administration of the trial drug until end of the trial, up to 31 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main objective of this trial is to investigate the basic pharmacokinetics of BI 1015550 and its metabolite BI 764333 (M480), \[14C\]-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose BI 1015550 (C-14) administered to healthy male subjects.
The primary objective is:
\- To assess the mass balance recovery of \[14C\]-radioactivity from urine and faeces as well as vomit in case of occurrence after a single oral dose of BI 1015550 (C-14) administered to healthy male subjects
The secondary objectives are:
* To assess the pharmacokinetics of \[C-14\]-BI 1015550 and BI 1015550 as well as its metabolite BI 764333 in plasma following a single oral dose of BI 1015550 (C-14)
* To assess the safety and tolerability of BI 1015550
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 28 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04771286.