A Phase 1 interventional study of BI 1569912 (C-14) and BI 1569912 (C-13) in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
The main objectives of this trial are:
Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will only be included in the trial if they meet the following criteria:
Exclusion Criteria :
Subjects will not be allowed to participate, if any of the following general criteria apply:
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.
Drug: BI 1569912 (C-14) · Drug: BI 1569912 (C-13)
10 milligram (mg) \[14C\]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
Also known as: NR2B NAM
A single dose of 100 microgram (µg) \[13C\]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.
Also known as: NR2B NAM
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
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).
Time frame: Up to 14 days.
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
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.
Time frame: Up to 14 days.
Total Recovery of [14C]-Radioactivity
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.
Time frame: Up to 14 days.
Area Under the Concentration-time Curve of BI 1569912 Over the Time Interval From 0 Extrapolated to Infinity in Plasma (AUC0-∞)
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.
Time frame: 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.
Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
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).
Time frame: 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.
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)
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).
Time frame: 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.
This was a non-randomised, open-label, single-dose, fixed sequence trial in healthy male participants.
| Milestone | 10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference) |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
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).
| Percentage of administered dose | 10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) |
|---|---|
| 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 | 57.0 ± 10.9 |
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.
| Percentage of administered dose | 10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) |
|---|---|
| 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 | 31.1 ± 62.9 |
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.
| Percentage of administered dose | 10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) |
|---|---|
| Total Recovery of [14C]-Radioactivity | 91.2 ± 12.7 |
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.
| hours*millimole/Liter/kilogram | 10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) | 100 Microgram (µg) BI 1569912 (C-13) Solution for i.v. Infusion (Reference Treatment) |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1569912 Over the Time Interval From 0 Extrapolated to Infinity in Plasma (AUC0-∞) | 122.1 ± na | 193.59 ± na |
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).
| nanomole/Liter | 100 Microgram (µg) BI 1569912 (C-13) Solution for i.v. Infusion (Reference Treatment) | 10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) | 10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) - Unlabeled |
|---|---|---|---|
| Maximum Measured Concentration of BI 1569912 in Plasma (Cmax) | 8.59 ± 43.8 | 729 ± 23.8 | 431 ± 24.4 |
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).
| hours*nanomole/Liter | 100 Microgram (µg) BI 1569912 (C-13) Solution for i.v. Infusion (Reference Treatment) | 10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) | 10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) - Unlabeled |
|---|---|---|---|
| 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) | 17.9 ± 18.2 | 10600 ± 28.2 | 1220 ± 22.9 |
Collected over For Adverse Events: Up to 36 hours For All-Cause Mortality: up to 14 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference) | 0/8 (0%) | 0/8 (0%) | 5/8 (62.5%) |
| Event | 10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference) |
|---|---|
| Catheter site bruiseGeneral disorders | 2/8 |
| Catheter site erythemaGeneral disorders | 1/8 |
| FatigueGeneral disorders | 1/8 |
| Infusion site inflammationGeneral disorders | 1/8 |
| DizzinessNervous system disorders | 1/8 |
| Depressed moodPsychiatric disorders | 1/8 |
Treated set (TS): all subjects who were treated with at least one dose of trial drug.
| Age, Continuous(Years) | 10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference) |
|---|---|
| Mean | 34.9 ± 8.6 |
| Sex: Female, Male(Participants) | 10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference) |
|---|---|
| Female | 0 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | 10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | 10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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