HealthyPhase 1NCT04445090

A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated and How Food Influences the Amount of BI 1569912 in the Blood

A Phase 1 study testing BI 1569912 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

SRD-Part: To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses (SRD) of BI 1569912 BA/FE-Part: To investigate (a) the relative bioavailability (BA) of BI 1569912 and (b) the influence of food (FE) on the relative bioavailability of BI 1569912 Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 1569912
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteGermany
Study dates: 21 Jul 2020to 10 Sep 2021
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 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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), respiratory rate (RR), temperature (T)), 12-lead ECG, and clinical laboratory tests
Age of 18 to 45 years (inclusive)
BMI of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
Use of adequate contraception, e.g. any of the following methods (of female partners) plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device

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Sexually abstinent
Surgically sterilised (including hysterectomy of female partner)
Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Who cannot join

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 50 to 90 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
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

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History of relevant orthostatic hypotension, fainting spells, or any unexplained blackouts
Chronic or relevant acute infections
A positive polymerase chain reaction (PCR) test for SARS-CoV-2/COVID-19 and/ or any clinical symptom suggestive for this disease at screening and on Day -3.
Further exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Charité - Universitätsmedizin Berlin
Berlin, 10117

Other trials in Germany

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1569912 in Healthy Male Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design) With an Additional Relative Bioavailability/ Food Effect Part (Open-label, Randomized, Three-way Crossover Design)

Conditions: Healthy
Being tested: BI 1569912, Placebo

What participants receive

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

BI 1569912Drug
BI 1569912
PlaceboDrug
Placebo

Study groups in NCT04445090
Study group	Role	What they receive
SRD part: Placebo	Placebo comparator	This arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Receives: Drug: Placebo
SRD part: 0.25mg BI 1569912	Experimental	Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Receives: Drug: BI 1569912
SRD part: 0.75mg BI 1569912	Experimental	Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Receives: Drug: BI 1569912
SRD part: 2.0 mg BI 1569912	Experimental	Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Receives: Drug: BI 1569912
SRD part: 5.0 mg BI 1569912	Experimental	Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Receives: Drug: BI 1569912
SRD part: 10.0 mg BI 1569912	Experimental	Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Receives: Drug: BI 1569912
SRD part: 20.0 mg BI 1569912	Experimental	Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Receives: Drug: BI 1569912
SRD part: 30.0 mg BI 1569912	Experimental	Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Receives: Drug: BI 1569912
BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fasted/5.0 mg tablet fed	Experimental	Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorized employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. Receives: Drug: BI 1569912
BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fed/5.0 mg tablet fasted	Experimental	Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. Receives: Drug: BI 1569912
BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg oral solution fasted/5.0 mg tablet fed	Experimental	Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. Receives: Drug: BI 1569912
BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg tablet fed/5.0 mg oral solution fasted	Experimental	Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. Receives: Drug: BI 1569912
BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg oral solution fasted/5.0 mg tablet fasted	Experimental	Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. Receives: Drug: BI 1569912
BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg tablet fasted/5.0 mg oral solution fasted	Experimental	Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments. Receives: Drug: BI 1569912

What is being measured

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

Part SRD: Number of Subjects With Drug-related Adverse Events (AEs)
Number of participants with drug-related adverse events (AEs) is presented for SRD part. Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported.
Percentages are calculated using total number of subjects per treatment as the denominator.
Measured: From drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. Up to 14.5 days.
BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
Measured: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
BA/FE-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Maximum measured concentration of BI 1569912 in plasma (Cmax) is presented.
Measured: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.

Secondary outcomes (3)

SRD Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to infinity (AUC0-∞) is presented.
Measured: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.
SRD-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Maximum measured concentration of BI 1569912 in plasma (Cmax) is presented.
Measured: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.
BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to infinity (AUC0-∞) is presented.
Measured: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.

Timeline

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

21 Jul 202010 Sep 2021

First posted24 Jun 2020
Study start21 Jul 2020
Primary completion10 Sep 2021
Study completion10 Sep 2021

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.
Publications (1)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Model description: SRD-Part: parallel-group design BA/FE-Part: three-way crossover design
Masking: Single blind
Who is masked: Participant
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04445090
Sponsor's protocol ID: 1447-0001
Other IDs: 2019-004836-51, 2019
Status last verified: Apr 2026
First submitted: 22 Jun 2020
Last updated: 22 May 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
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, except for the following exclusions: 1\. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Publications

Hunnemeyer A, Ogama Y, De Crescenzo F, Goeldner RG, Harada A, Katakabe T, Scholz A, Shatillo Y, Sussmuth SD, Keicher C. Safety, tolerability and pharmacokinetics of an NMDA receptor subunit 2B-selective negative allosteric modulator, BI 1569912: Results of three partially randomised, placebo-controlled phase I trials. J Psychopharmacol. 2026 Sep 2:2698811261481073. doi: 10.1177/02698811261481073. Online ahead of print.
PubMed 42684025

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?

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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: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1569912 in Healthy Male Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design) With an Additional Relative Bioavailability/ Food Effect Part (Open-label, Randomized, Three-way Crossover Design)
ClinicalTrials.gov ID: NCT04445090
Acronym / sponsor ID: 1447-0001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 68 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 21 Jul 2020 (actual)
Primary completion: 10 Sep 2021 (actual)
Study completion: 10 Sep 2021 (actual)
First posted: 24 Jun 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 14
Model description: SRD-Part: parallel-group design BA/FE-Part: three-way crossover design

Arm	Type	Receives
SRD part: Placebo	Placebo comparator	Drug: PlaceboThis arm comprises all placebo treated participants in trial part SRD, regardless of the dose group in which they were treated. Participants were randomized within each dose group in a 3:1 ratio (test treatment to placebo). Participants were administered on Day 1 a single oral dose of matching placebo (the matching placebo is only the solvent for oral solution (Tartaric acid 5 mg/mL) on a volume identical to dose group (DG) of active treatment ) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
SRD part: 0.25mg BI 1569912	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single oral dose of 0.25 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 0.4 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
SRD part: 0.75mg BI 1569912	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single oral dose of 0.75 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 1.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
SRD part: 2.0 mg BI 1569912	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single oral dose of 2.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 3.2 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
SRD part: 5.0 mg BI 1569912	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single oral dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
SRD part: 10.0 mg BI 1569912	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single oral dose of 10.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 16 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
SRD part: 20.0 mg BI 1569912	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single oral dose of 20.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 32 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
SRD part: 30.0 mg BI 1569912	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single oral dose of 30.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 48 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning.
BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fasted/5.0 mg tablet fed	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorized employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.
BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fed/5.0 mg tablet fasted	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.
BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg oral solution fasted/5.0 mg tablet fed	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.
BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg tablet fed/5.0 mg oral solution fasted	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.
BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg oral solution fasted/5.0 mg tablet fasted	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.
BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg tablet fasted/5.0 mg oral solution fasted	Experimental	Drug: BI 1569912Participants were administered on Day 1 a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after a high-fat, high-calorie meal served 30 min before drug administration. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 tablet together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. Followed by a single dose of 5.0 milligram (mg) of BI 1569912 powder for reconstitution of an oral solution (PfoS) reconstituted in solvent for oral solution 8 milliliter (mL) (Tartaric acid 5 mg/mL) together with about 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in the morning. One authorised employee of the trial site witnessed the administration of trial medication. The treatments were separated by a washout phase of at least 5 days between treatments.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 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), respiratory rate (RR), temperature (T)), 12-lead ECG, and clinical laboratory tests
Age of 18 to 45 years (inclusive)
BMI of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

Key exclusion criteria (10 listed)

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 50 to 90 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
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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 1569912BI 1569912	Drug	BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fasted/5.0 mg tablet fed, BA/FE Part: BI 1569912 5.0 mg oral solution fasted/5.0 mg tablet fed/5.0 mg tablet fasted, BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg oral solution fasted/5.0 mg tablet fed, BA/FE Part: BI 1569912 5.0 mg tablet fasted/5.0 mg tablet fed/5.0 mg oral solution fasted, BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg oral solution fasted/5.0 mg tablet fasted, BA/FE Part: BI 1569912 5.0 mg tablet fed/5.0 mg tablet fasted/5.0 mg oral solution fasted, SRD part: 0.25mg BI 1569912, SRD part: 0.75mg BI 1569912, SRD part: 10.0 mg BI 1569912, SRD part: 2.0 mg BI 1569912, SRD part: 20.0 mg BI 1569912, SRD part: 30.0 mg BI 1569912, SRD part: 5.0 mg BI 1569912
PlaceboPlacebo	Drug	SRD part: Placebo

Primary outcome

Part SRD: Number of Subjects With Drug-related Adverse Events (AEs)
Time frame: From drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. Up to 14.5 days.
Number of participants with drug-related adverse events (AEs) is presented for SRD part. Percentage of participants with treatment-emergent drug-related Adverse Events (AEs) is reported. Percentages are calculated using total number of subjects per treatment as the denominator.
BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
Area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
BA/FE-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Time frame: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.
Maximum measured concentration of BI 1569912 in plasma (Cmax) is presented.

3 secondary outcomes

SRD Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)
Time frame: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.
SRD-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Time frame: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h30min, 2h30min, 3h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, after BI 1569912 administration.
BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to Infinity (AUC0-∞)
Time frame: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.

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
SRD Part: Placebo	14	13
SRD Part: 0.25mg BI 1569912	6	6
SRD Part: 0.75mg BI 1569912	6	6
SRD Part: 2.0 mg BI 1569912	6	6
SRD Part: 5.0 mg BI 1569912	6	6
SRD Part: 10.0 mg BI 1569912	6	6
SRD Part: 20.0 mg BI 1569912	6	6
SRD Part: 30.0 mg BI 1569912	5	5
BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted/5.0 mg Tablet Fasted/5.0 mg Tablet Fed	2	2
BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted/5.0 mg Tablet Fed/5.0 mg Tablet Fasted	3	0
BA/FE Part: BI 1569912 5.0 mg Tablet Fasted/5.0 mg Oral Solution Fasted/5.0 mg Tablet Fed	2	2
BA/FE Part: BI 1569912 5.0 mg Tablet Fasted/5.0 mg Tablet Fed/5.0 mg Oral Solution Fasted	2	2
BA/FE Part: BI 1569912 5.0 mg Tablet Fed/5.0 mg Oral Solution Fasted/5.0 mg Tablet Fasted	2	0
BA/FE Part: BI 1569912 5.0 mg Tablet Fed/5.0 mg Tablet Fasted/5.0 mg Oral Solution Fasted	2	2

Primary outcome: Part SRD: Number of Subjects With Drug-related Adverse Events (AEs)

Time frame: From drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. Up to 14.5 days.. Count of participants. Unit: Participants

Measure	SRD Part: Placebo n = 14	SRD Part: 0.25mg BI 1569912 n = 6	SRD Part: 0.75mg BI 1569912 n = 6	SRD Part: 2.0 mg BI 1569912 n = 6	SRD Part: 5.0 mg BI 1569912 n = 6	SRD Part: 10.0 mg BI 1569912 n = 6	SRD Part: 20.0 mg BI 1569912 n = 6	SRD Part: 30.0 mg BI 1569912 n = 5
Value	1	0	0	2	0	0	1	2

Population analysed: Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug.

Primary outcome: BA/FE-Part: Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: Within 3 hours (h) prior administration and, 5min, 15min, 30min, 45min, 1h, 1h15min, 1h30min, 2h, 2h30min, 3h, 4h, 6h, 8h, 12h, 14h, 24h, 36h, 48h, 72h, after BI 1569912 administration.. Geometric least squares mean (Standard Error). Unit: hours * nanomole/Liter

Measure	BA/FE Part: BI 1569912 5.0 mg Tablet Fasted n = 5	BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted n = 10	BA/FE Part: BI 1569912 5.0 mg Tablet Fed n = 11
Value	588.8 (NA)	567.5 (NA)	575.2 (NA)

BA/FE Part: BI 1569912 5.0 mg Tablet Fasted vs BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted: Ratio of adjusted geometric means (%): 103.8 (90% CI 99.0 to 108.7)
BA/FE Part: BI 1569912 5.0 mg Tablet Fasted vs BA/FE Part: BI 1569912 5.0 mg Tablet Fed: Ratio of adjusted geometric means (%): 97.7 (90% CI 93.4 to 102.2)

Population analysed: Pharmacokinetic parameter analysis set (PKS): This set includes all subjects in the treated set (TS) who provide at least one primary or secondary pharmacokinetic endpoint that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetics or due to pharmacokinetic non-evaluability. Only subjects with non-missing values were included.

Primary outcome: BA/FE-Part: Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)

Measure	BA/FE Part: BI 1569912 5.0 mg Tablet Fasted n = 8	BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted n = 12	BA/FE Part: BI 1569912 5.0 mg Tablet Fed n = 11
Value	201.5 (NA)	188.0 (NA)	134.5 (NA)

BA/FE Part: BI 1569912 5.0 mg Tablet Fasted vs BA/FE Part: BI 1569912 5.0 mg Tablet Fed: Ratio of adjusted geometric means (%): 66.7 (90% CI 54.2 to 82.1)
BA/FE Part: BI 1569912 5.0 mg Tablet Fasted vs BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted: Ratio of adjusted geometric means (%): 107.2 (90% CI 87.1 to 131.9)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: SRD part: from drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. SRD part all-cause mortality: up to 14.5 days. BA/FE part: from drug administration until date/time of administration of study drug in next period or 12:00 AM on day after last contact date, which ever occurs first. BA/FE part all-cause mortality: up to 26.5 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SRD Part: Placebo	0 of 14 (0%)	1 of 14 (7.1%)	0 of 14
SRD Part: 0.25mg BI 1569912	0 of 6 (0%)	0 of 6 (0%)	0 of 6
SRD Part: 0.75mg BI 1569912	0 of 6 (0%)	0 of 6 (0%)	0 of 6
SRD Part: 2.0 mg BI 1569912	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
SRD Part: 5.0 mg BI 1569912	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
SRD Part: 10.0 mg BI 1569912	0 of 6 (0%)	0 of 6 (0%)	0 of 6
SRD Part: 20.0 mg BI 1569912	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
SRD Part: 30.0 mg BI 1569912	0 of 5 (0%)	2 of 5 (40%)	0 of 5
BA/FE Part: BI 1569912 5.0 mg Tablet Fasted	0 of 8 (0%)	0 of 8 (0%)	0 of 8
BA/FE Part: BI 1569912 5.0 mg Tablet Fed	0 of 11 (0%)	0 of 11 (0%)	0 of 11
BA/FE Part: BI 1569912 5.0 mg Oral Solution Fasted	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): The trial was set on temporary hold on 06 Sep 2021 and was terminated on 07 Oct 2021 due to the identification of a metabolite of BI 1569912 which was classified as Class 2 substance (according to ICH M7 \[R1\] guideline) as a result of a positive Ames test. Further analysis is ongoing to find out if BI 1569912 can safely be dosed in subsequent trials.

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.
Derived from this study: PubMed 42684025Hunnemeyer A, Ogama Y, De Crescenzo F, Goeldner RG, Harada A, Katakabe T, Scholz A, Shatillo Y, Sussmuth SD, Keicher C. Safety, tolerability and pharmacokinetics of an NMDA receptor subunit 2B-selective negative allosteric modulator, BI 1569912: Results of three partially randomised, placebo-controlled phase I trials. J Psychopharmacol. 2026 Sep 2:2698811261481073. doi: 10.1177/02698811261481073. Online ahead of print.
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, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

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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 in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

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 9 inclusion and 10 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: stopped early, 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 Germany. 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. Some participants in this study may receive a placebo. 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?

Part SRD: Number of Subjects With Drug-related Adverse Events (AEs) (time frame: From drug administration until end of residual effect period of 36 hours (h) or 12:00 AM on day after last contact date (could be the end of trial visit), which ever occurs first. Up to 14.5 days.). The study lists 3 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 NCT04445090, which also lists 1 linked publication.

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.