Trial Outcomes & Findings for A Study in Healthy Men to Find Out How BI 1015550 is Taken up and Handled by the Body (NCT NCT04771286)
NCT ID: NCT04771286
Last Updated: 2025-11-28
Results Overview
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 + 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216 h after drug administration. Thereafter, if warranted, 24 h collections for urine and faeces were to be performed every 7 days starting on Day 16, at Day 16-17, Day 23-24, Day 30-31. When the release criteria for radioactivity recovery had been met then urine/faeces sampling was stopped (earliest stop on Day 10).
COMPLETED
PHASE1
6 participants
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.
2025-11-28
Participant Flow
This is a phase I, open-label, non-randomized, single-dose, single-arm, single-period study to investigate the basic pharmacokinetics (PK) of BI 1015550 and its metabolite BI 764333 (M480), \[14C\]-radioactivity, including mass balance, excretion pathways, and metabolism following a single oral dose of BI 1015550 (C-14) administered to healthy male subjects.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
BI 1015550 (C-14)
Participants received a single dose of 18 milligram (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg \[14C\]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours.
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|---|---|
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Men to Find Out How BI 1015550 is Taken up and Handled by the Body
Baseline characteristics by cohort
| Measure |
BI 1015550 (C-14)
n=6 Participants
Participants received a single dose of 18 milligram (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg \[14C\]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours.
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Age, Continuous
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44.3 Years
STANDARD_DEVIATION 17.7 • n=30 Participants
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Sex: Female, Male
Female
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0 Participants
n=30 Participants
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Sex: Female, Male
Male
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6 Participants
n=30 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=30 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=30 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=30 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=30 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=30 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=30 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=30 Participants
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Race (NIH/OMB)
White
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4 Participants
n=30 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=30 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=30 Participants
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PRIMARY outcome
Timeframe: 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.Population: Treated set (TS): The TS set included all subjects who were entered and treated with the single dose of the trial drug. There was no occurrence of vomit among the participants therefore number of participants analyzed is zero for fevomit,0-tz.
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 + 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216 h after drug administration. Thereafter, if warranted, 24 h collections for urine and faeces were to be performed every 7 days starting on Day 16, at Day 16-17, Day 23-24, Day 30-31. When the release criteria for radioactivity recovery had been met then urine/faeces sampling was stopped (earliest stop on Day 10).
Outcome measures
| Measure |
BI 1015550 (C-14)
n=6 Participants
Participants received a single dose of 18 milligram (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg \[14C\]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours.
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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)
urine
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36.4 Percentage of administered dose
Geometric Coefficient of Variation 11.8
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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)
faeces
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58.0 Percentage of administered dose
Geometric Coefficient of Variation 12.7
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SECONDARY outcome
Timeframe: 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.Population: Pharmacokinetic parameter analysis set (PKS): PKS included all subjects in TS who provided at least 1 pharmacokinetics (PK) endpoint that was defined as primary or secondary and was not excluded due to protocol violation relevant to evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment.
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.
Outcome measures
| Measure |
BI 1015550 (C-14)
n=6 Participants
Participants received a single dose of 18 milligram (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg \[14C\]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours.
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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)
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2850 hours*nanomole/Liter
Geometric Coefficient of Variation 19.5
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SECONDARY outcome
Timeframe: 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.Population: Pharmacokinetic parameter analysis set (PKS): PKS included all subjects in TS who provided at least 1 pharmacokinetics (PK) endpoint that was defined as primary or secondary and was not excluded due to protocol violation relevant to evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment.
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.
Outcome measures
| Measure |
BI 1015550 (C-14)
n=6 Participants
Participants received a single dose of 18 milligram (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg \[14C\]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours.
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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)
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672 hours*nanomole/Liter
Geometric Coefficient of Variation 32.9
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SECONDARY outcome
Timeframe: 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.Population: Pharmacokinetic parameter analysis set (PKS): PKS included all subjects in TS who provided at least 1 pharmacokinetics (PK) endpoint that was defined as primary or secondary and was not excluded due to protocol violation relevant to evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment.
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.
Outcome measures
| Measure |
BI 1015550 (C-14)
n=6 Participants
Participants received a single dose of 18 milligram (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg \[14C\]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours.
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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)
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10600 hours*nanomole/Liter
Geometric Coefficient of Variation 25.6
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SECONDARY outcome
Timeframe: 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.Population: Pharmacokinetic parameter analysis set (PKS): PKS included all subjects in TS who provided at least 1 pharmacokinetics (PK) endpoint that was defined as primary or secondary and was not excluded due to protocol violation relevant to evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment.
Maximum measured concentration of BI 1015550 in plasma (Cmax) is presented.
Outcome measures
| Measure |
BI 1015550 (C-14)
n=6 Participants
Participants received a single dose of 18 milligram (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg \[14C\]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours.
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Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
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544 nanomole/Liter
Geometric Coefficient of Variation 11.8
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SECONDARY outcome
Timeframe: 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.Population: Pharmacokinetic parameter analysis set (PKS): PKS included all subjects in TS who provided at least 1 pharmacokinetics (PK) endpoint that was defined as primary or secondary and was not excluded due to protocol violation relevant to evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment.
Maximum measured concentration of BI 764333 in plasma (Cmax) is presented. BI 764333 is a metabolite of BI 1015550.
Outcome measures
| Measure |
BI 1015550 (C-14)
n=6 Participants
Participants received a single dose of 18 milligram (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg \[14C\]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours.
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Maximum Measured Concentration of BI 764333 in Plasma (Cmax)
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13.0 nanomole/Liter
Geometric Coefficient of Variation 29.2
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SECONDARY outcome
Timeframe: 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.Population: Pharmacokinetic parameter analysis set (PKS): PKS included all subjects in TS who provided at least 1 pharmacokinetics (PK) endpoint that was defined as primary or secondary and was not excluded due to protocol violation relevant to evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if the subject contributed only 1 PK parameter value for 1 period to the statistical assessment.
Maximum measured concentration of \[14-C\] BI 1015550-EQ in plasma (Cmax) is presented.
Outcome measures
| Measure |
BI 1015550 (C-14)
n=6 Participants
Participants received a single dose of 18 milligram (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg \[14C\]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours.
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Maximum Measured Concentration of [14-C] BI 1015550-EQ in Plasma (Cmax)
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606 nanomole/Liter
Geometric Coefficient of Variation 12.4
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SECONDARY outcome
Timeframe: From the first administration of the trial drug until end of the trial, up to 31 days.Population: Treated set (TS): The TS set included all subjects who were entered and treated with the single dose of the trial drug.
Percentage of participants with treatment-emergent adverse events (TEAE) is presented. Percentages were rounded to one decimal place.
Outcome measures
| Measure |
BI 1015550 (C-14)
n=6 Participants
Participants received a single dose of 18 milligram (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg \[14C\]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours.
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Percentage of Participants With Treatment-emergent Adverse Events (TEAE)
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66.7 Percentage of participants
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Adverse Events
BI 1015550 (C-14)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 1015550 (C-14)
n=6 participants at risk
Participants received a single dose of 18 milligram (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg \[14C\]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours.
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Gastrointestinal disorders
Abdominal discomfort
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16.7%
1/6 • "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.
Treated set (TS): The TS set included all subjects who were entered and treated with the single dose of the trial drug.
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Gastrointestinal disorders
Diarrhoea
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16.7%
1/6 • "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.
Treated set (TS): The TS set included all subjects who were entered and treated with the single dose of the trial drug.
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Nervous system disorders
Headache
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33.3%
2/6 • "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.
Treated set (TS): The TS set included all subjects who were entered and treated with the single dose of the trial drug.
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Respiratory, thoracic and mediastinal disorders
Epistaxis
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16.7%
1/6 • "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.
Treated set (TS): The TS set included all subjects who were entered and treated with the single dose of the trial drug.
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Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER