HealthyPhase 1NCT06520553

A Study in Healthy Men to Test How BI 1569912 is Processed in the Body

A Phase 1 study testing BI 1569912 (C-14) and BI 1569912 (C-13) in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objectives of this trial are: To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T). Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 1569912 (C-14) and BI 1569912 (C-13)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteNetherlands
Study dates: 26 Aug 2024to 3 Oct 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Subjects will only be included in the trial if they meet the following criteria:
Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m 2 (inclusive)
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Who cannot join

Subjects will not be allowed to participate, if any of the following general criteria apply:
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 40 to 100 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

ICON-Groningen-62040
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A Double-micro-tracer Human Absorption, Distribution, Metabolism and Excretion (hADME) and Absolute Bioavailability Trial After a Single Oral Dose of BI 1569912 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1569912 (C-13) in Healthy Male Subjects (a Phase I, Open-label, Non-randomised, Single-dose, Fixed-sequence Trial)

The main objectives of this trial are:

To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T).
To investigate the absolute bioavailability of BI 1569912 as single oral solution dose, using a single, concomitant intravenous micro-tracer administration of BI 1569912 (C-13) (reference treatment, R)

Conditions: Healthy
Being tested: BI 1569912 (C-14), BI 1569912 (C-13)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 1569912 (C-14)Drug
Also called NR2B NAM
10 milligram (mg) [14C]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.
BI 1569912 (C-13)Drug
Also called NR2B NAM
A single dose of 100 microgram (µg) [13C]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.

Study groups in NCT06520553
Study group	Role	What they receive
10 mg BI 1569912 (C-14) oral solution (test) - 100 μg BI 1569912 (C-13) i.v. infusion (reference)	Experimental	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. Receives: Drug: BI 1569912 (C-14); Drug: BI 1569912 (C-13)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.

Secondary outcomes (2)

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).
Measured: 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).
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Aug 20243 Oct 2024

First posted25 Jul 2024
Study start26 Aug 2024
Primary completion3 Oct 2024
Study completion3 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06520553
Sponsor's protocol ID: 1447-0010
Other IDs: 2023-510464-12-00, U1111-1302-4229, 2023
Status last verified: Apr 2026
First submitted: 22 Jul 2024
Last updated: 22 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-micro-tracer Human Absorption, Distribution, Metabolism and Excretion (hADME) and Absolute Bioavailability Trial After a Single Oral Dose of BI 1569912 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1569912 (C-13) in Healthy Male Subjects (a Phase I, Open-label, Non-randomised, Single-dose, Fixed-sequence Trial)
ClinicalTrials.gov ID: NCT06520553
Acronym / sponsor ID: 1447-0010
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 26 Aug 2024 (actual)
Primary completion: 3 Oct 2024 (actual)
Study completion: 3 Oct 2024 (actual)
First posted: 25 Jul 2024 (actual)
Results: Posted 22 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main objectives of this trial are:

To investigate basic pharmacokinetics of BI 1569912 and total radioactivity, including mass balance, excretion pathways and metabolism following oral administration of BI 1569912 (C-14) to healthy male subjects (test treatment, T).
To investigate the absolute bioavailability of BI 1569912 as single oral solution dose, using a single, concomitant intravenous micro-tracer administration of BI 1569912 (C-13) (reference treatment, R)

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
10 mg BI 1569912 (C-14) oral solution (test) - 100 μg BI 1569912 (C-13) i.v. infusion (reference)	Experimental	Drug: BI 1569912 (C-14), Drug: BI 1569912 (C-13)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.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (inclusive)
Body mass index (BMI) of 18.5 to 29.9 kg/m 2 (inclusive)
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Key exclusion criteria (6 listed)

Subjects will not be allowed to participate, if any of the following general criteria apply:
Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 40 to 100 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements
Any evidence of a concomitant disease assessed as clinically relevant by the investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 1569912 (C-14)Also: NR2B NAM10 milligram (mg) [14C]-labeled BI 1569912 mixed with unlabeled BI 1569912 taken as an oral solution.	Drug	10 mg BI 1569912 (C-14) oral solution (test) - 100 μg BI 1569912 (C-13) i.v. infusion (reference)
BI 1569912 (C-13)Also: NR2B NAMA single dose of 100 microgram (µg) [13C]-labeled BI 1569912 taken as an intravenous (i.v.) infusion.	Drug	10 mg BI 1569912 (C-14) oral solution (test) - 100 μg BI 1569912 (C-13) i.v. infusion (reference)

Primary outcome

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
Time frame: Up to 14 days.
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).
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.
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.
Total Recovery of [14C]-Radioactivity
Time frame: Up to 14 days.
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.
Area Under the Concentration-time Curve of BI 1569912 Over the Time Interval From 0 Extrapolated to Infinity in Plasma (AUC0-∞)
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 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.

2 secondary outcomes

Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
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)
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.

Results and safety

Results posted to the registry on 22 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference)	8	8

Primary outcome: 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

Time frame: Up to 14 days.. Geometric mean (Geometric Coefficient of Variation). Unit: Percentage of administered dose

Measure	10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) n = 8
Value	57.0 (10.9)

Population analysed: 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.

Primary outcome: 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.. Geometric mean (Geometric Coefficient of Variation). Unit: Percentage of administered dose

Measure	10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) n = 8
Value	31.1 (62.9)

Primary outcome: Total Recovery of [14C]-Radioactivity

Time frame: Up to 14 days.. Geometric mean (Geometric Coefficient of Variation). Unit: Percentage of administered dose

Measure	10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) n = 8
Value	91.2 (12.7)

Primary outcome: Area Under the Concentration-time Curve of BI 1569912 Over the Time Interval From 0 Extrapolated to Infinity in Plasma (AUC0-∞)

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.. Geometric least squares mean (Standard Error). Unit: hours*millimole/Liter/kilogram

Measure	10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) n = 8	100 Microgram (µg) BI 1569912 (C-13) Solution for i.v. Infusion (Reference Treatment) n = 8
Value	122.1 (na)	193.59 (na)

10 Milligram (mg) BI 1569912 (C-14) Oral Solution (Test Treatment) vs 100 Microgram (µg) BI 1569912 (C-13) Solution for i.v. Infusion (Reference Treatment): Ratio (%): 63.07 (90% CI 60.03 to 66.27)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: For Adverse Events: Up to 36 hours For All-Cause Mortality: up to 14 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10 mg BI 1569912 (C-14) Oral Solution (Test) - 100 μg BI 1569912 (C-13) i.v. Infusion (Reference)	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 1569912 (C-14) and BI 1569912 (C-13) in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to 14 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06520553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.