Trial Outcomes & Findings for A Study in Healthy Men to Test How BI 1569912 is Processed in the Body (NCT NCT06520553)
NCT ID: NCT06520553
Last Updated: 2026-05-22
Results Overview
Mass balance recovery for \[14C\]-radioactivity in urine after oral administration of BI 1569912 (C-14): Fraction 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).
COMPLETED
PHASE1
8 participants
Up to 14 days.
2026-05-22
Participant Flow
This was a non-randomised, open-label, single-dose, fixed sequence trial in healthy male participants.
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 |
10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference)
Healthy male participants received a single dose of 10 milligram (mg) \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution and 30 minutes later received a single dose of 100 microgram (µg) \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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8
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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 Test How BI 1569912 is Processed in the Body
Baseline characteristics by cohort
| Measure |
10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference)
n=8 Participants
Healthy male participants received a single dose of 10 milligram (mg) \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution and 30 minutes later received a single dose of 100 microgram (µg) \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.
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Age, Continuous
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34.9 Years
STANDARD_DEVIATION 8.6 • n=2 Participants
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Sex: Female, Male
Female
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0 Participants
n=2 Participants
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Sex: Female, Male
Male
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8 Participants
n=2 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=2 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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8 Participants
n=2 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=2 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=2 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=2 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=2 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=2 Participants
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Race (NIH/OMB)
White
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8 Participants
n=2 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=2 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=2 Participants
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PRIMARY outcome
Timeframe: Up to 14 days.Population: Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set (TS) who provided at least one PK endpoint that was defined as primary or secondary and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Mass balance recovery for \[14C\]-radioactivity in urine after oral administration of BI 1569912 (C-14): Fraction 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).
Outcome measures
| Measure |
10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment)
n=8 Participants
Healthy male participants received a single dose of 10 mg \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
|
100 Microgram (µg) BI 1569912 (C-13) Solution for i.v. Infusion (Reference Treatment)
Healthy male participants received a single dose of 100 µg \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.
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10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) - Unlabeled
Healthy male participants received a single dose of 10 mg \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
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|---|---|---|---|
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Fraction 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) of [14C]-Radioactivity
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57.0 Percentage of administered dose
Geometric Coefficient of Variation 10.9
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—
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—
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PRIMARY outcome
Timeframe: Up to 14 days.Population: Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set (TS) who provided at least one PK endpoint that was defined as primary or secondary and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Mass balance recovery for \[14C\]-radioactivity in faeces after oral administration of BI 1569912 (C-14): Fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fe faeces,0-tz) of \[14C\]-radioactivity.
Outcome measures
| Measure |
10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment)
n=8 Participants
Healthy male participants received a single dose of 10 mg \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
|
100 Microgram (µg) BI 1569912 (C-13) Solution for i.v. Infusion (Reference Treatment)
Healthy male participants received a single dose of 100 µg \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.
|
10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) - Unlabeled
Healthy male participants received a single dose of 10 mg \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
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|---|---|---|---|
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Fraction Excreted in Faeces as Percentage of the Administered Dose Over the Time Interval From 0 to the Last Quantifiable Time Point (fe Faeces,0-tz) of [14C]-Radioactivity
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31.1 Percentage of administered dose
Geometric Coefficient of Variation 62.9
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—
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—
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PRIMARY outcome
Timeframe: Up to 14 days.Population: Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set (TS) who provided at least one PK endpoint that was defined as primary or secondary and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Mass balance recovery for \[14C\]-radioactivity in urine and faeces after oral administration of BI 1569912 (C-14). The total recovery is calculated based on the individual values and hence can differ from the sum of the urine and faeces gMean values.
Outcome measures
| Measure |
10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment)
n=8 Participants
Healthy male participants received a single dose of 10 mg \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
|
100 Microgram (µg) BI 1569912 (C-13) Solution for i.v. Infusion (Reference Treatment)
Healthy male participants received a single dose of 100 µg \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.
|
10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) - Unlabeled
Healthy male participants received a single dose of 10 mg \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
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Total Recovery of [14C]-Radioactivity
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91.2 Percentage of administered dose
Geometric Coefficient of Variation 12.7
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—
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—
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PRIMARY outcome
Timeframe: Within 3 hours before and 0.25*, 0.5#, 0.58, 0.66*, 0.75, 0.92*, 1.08, 1.25*, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 192# and 288# hours following drug administration. *reference treatment only, #test treatment only.Population: Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set (TS) who provided at least one PK endpoint that was defined as primary or secondary and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of BI 1569912 over the time interval from 0 extrapolated to infinity in plasma (AUC0-∞) for BI 1569912 and \[13C\]-BI 1569912 after a single oral administration of BI 1569912 (C-14) (test treatment) and a single concomitant intravenous administration of BI 1569912 (C-13) (reference treatment). The presented data was derived from an analysis of variance (ANOVA) on the logarithmic scale including the fixed effect for 'treatment' and 'subject' as a random effect.
Outcome measures
| Measure |
10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment)
n=8 Participants
Healthy male participants received a single dose of 10 mg \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
|
100 Microgram (µg) BI 1569912 (C-13) Solution for i.v. Infusion (Reference Treatment)
n=8 Participants
Healthy male participants received a single dose of 100 µg \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.
|
10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) - Unlabeled
Healthy male participants received a single dose of 10 mg \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
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|---|---|---|---|
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Area Under the Concentration-time Curve of BI 1569912 Over the Time Interval From 0 Extrapolated to Infinity in Plasma (AUC0-∞)
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122.1 hours*millimole/Liter/kilogram
Standard Error na
Geometric standard error = 1.07
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193.59 hours*millimole/Liter/kilogram
Standard Error na
Geometric standard error = 1.07
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—
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SECONDARY outcome
Timeframe: Within 3 hours before and 0.25*, 0.5#, 0.58, 0.66*, 0.75, 0.92*, 1.08, 1.25*, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 192# and 288# hours following drug administration. *reference treatment only, #test treatment only.Population: Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set (TS) who provided at least one PK endpoint that was defined as primary or secondary and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
Cmax (maximum measured concentration in plasma) of BI 1569912 and \[14C\]-radioactivity after a single oral administration of BI 1569912 (C-14) and of \[13C\]-BI 1569912 after a single intravenous administration of BI 1569912 (C-13).
Outcome measures
| Measure |
10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment)
n=8 Participants
Healthy male participants received a single dose of 10 mg \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
|
100 Microgram (µg) BI 1569912 (C-13) Solution for i.v. Infusion (Reference Treatment)
n=8 Participants
Healthy male participants received a single dose of 100 µg \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.
|
10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) - Unlabeled
n=8 Participants
Healthy male participants received a single dose of 10 mg \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
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Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
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8.59 nanomole/Liter
Geometric Coefficient of Variation 43.8
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729 nanomole/Liter
Geometric Coefficient of Variation 23.8
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431 nanomole/Liter
Geometric Coefficient of Variation 24.4
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SECONDARY outcome
Timeframe: Within 3 hours before and 0.25*, 0.5#, 0.58, 0.66*, 0.75, 0.92*, 1.08, 1.25*, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120, 192# and 288# hours following drug administration. *reference treatment only, #test treatment only.Population: Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set (TS) who provided at least one PK endpoint that was defined as primary or secondary and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.
AUC0-tz (area under the concentration-time curve over the time interval from 0 to the last quantifiable time point in plasma) of BI 1569912 and \[14C\]-radioactivity after a single oral administration of BI 1569912 (C-14) and of \[13C\]-BI 1569912 after a single intravenous administration of BI 1569912 (C-13).
Outcome measures
| Measure |
10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment)
n=8 Participants
Healthy male participants received a single dose of 10 mg \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
|
100 Microgram (µg) BI 1569912 (C-13) Solution for i.v. Infusion (Reference Treatment)
n=8 Participants
Healthy male participants received a single dose of 100 µg \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.
|
10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) - Unlabeled
n=8 Participants
Healthy male participants received a single dose of 10 mg \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
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|---|---|---|---|
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Area Under the Concentration-time Curve of BI 1569912 Over the Time Interval From 0 to the Last Quantifiable Time Point in Plasma (AUC 0-tz)
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17.9 hours*nanomole/Liter
Geometric Coefficient of Variation 18.2
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10600 hours*nanomole/Liter
Geometric Coefficient of Variation 28.2
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1220 hours*nanomole/Liter
Geometric Coefficient of Variation 22.9
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Adverse Events
10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference)
n=8 participants at risk
Healthy male participants received a single dose of 10 milligram (mg) \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution and 30 minutes later received a single dose of 100 microgram (µg) \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.
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General disorders
Infusion site inflammation
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12.5%
1/8 • For Adverse Events: Up to 36 hours For All-Cause Mortality: up to 14 days.
Treated set (TS): all subjects who were treated with at least one dose of trial drug.
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Nervous system disorders
Dizziness
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12.5%
1/8 • For Adverse Events: Up to 36 hours For All-Cause Mortality: up to 14 days.
Treated set (TS): all subjects who were treated with at least one dose of trial drug.
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Psychiatric disorders
Depressed mood
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12.5%
1/8 • For Adverse Events: Up to 36 hours For All-Cause Mortality: up to 14 days.
Treated set (TS): all subjects who were treated with at least one dose of trial drug.
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General disorders
Catheter site bruise
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25.0%
2/8 • For Adverse Events: Up to 36 hours For All-Cause Mortality: up to 14 days.
Treated set (TS): all subjects who were treated with at least one dose of trial drug.
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General disorders
Catheter site erythema
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12.5%
1/8 • For Adverse Events: Up to 36 hours For All-Cause Mortality: up to 14 days.
Treated set (TS): all subjects who were treated with at least one dose of trial drug.
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General disorders
Fatigue
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12.5%
1/8 • For Adverse Events: Up to 36 hours For All-Cause Mortality: up to 14 days.
Treated set (TS): all subjects who were treated with at least one dose of 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