HealthyPhase 1NCT04978506

A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated

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

Completed

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

Trial summary

The main objectives of this trial are to investigate (1) safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising doses of BI 1569912; (2) tolerability of BI 1569912 in an up-titrating dosing scheme. Read more about this study

Who is it for?: Ages 18 to 80 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: 83 participants
Where: 1 siteGermany
Study dates: 3 Sep 2021to 4 Jul 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 80 years
Men only
Healthy volunteers accepted
Adult, Older 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)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
MRD- and POSO-part: Age of 18 to 45 years (inclusive); ELDERLY-part: Age of 65 to 80 years (inclusive)
Body mass index (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

Show all 9Show fewer

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 millimetres of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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
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)
Diseases of the central nervous system (including but not limited to any kind of seizures/ convulsions or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or unexplained blackouts

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 Multiple Rising Oral Doses of BI 1569912 (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel Group Design) With an Optional Posology (Uptitration) Part (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel Group Design) in Healthy Male Subjects

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 NCT04978506
Study group	Role	What they receive
Placebo group for MRD part	Placebo comparator	Healthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water. Receives: Drug: Placebo
Placebo for elderly treatment group	Placebo comparator	Elderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water. Receives: Drug: Placebo
BI 1569912 2.5 mg treatment group (MRD)	Experimental	Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. Receives: Drug: BI 1569912
BI 1569912 5 mg treatment group (MRD)	Experimental	Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. Receives: Drug: BI 1569912
BI 1569912 10 mg treatment group (MRD)	Experimental	Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. Receives: Drug: BI 1569912
BI 1569912 20 mg treatment group (MRD)	Experimental	Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. Receives: Drug: BI 1569912
BI 1569912 30 mg treatment group (MRD)	Experimental	Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. Receives: Drug: BI 1569912
BI 1569912 40 mg treatment group (MRD)	Experimental	Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study. Receives: Drug: BI 1569912
BI 1569912 elderly 10/20 mg treatment group	Experimental	Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water. Receives: Drug: BI 1569912

What is being measured

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

Number of Subjects With Drug-related Adverse Events
Number of subjects with drug-related adverse events is reported.
Measured: Up to Day 27

Secondary outcomes (7)

Area Under the Concentration-time Curve of BI 1569912 in Plasma Over a Uniform Dosing Interval of 24 h After Administration of the First Dose (AUC0-24)
Area under the concentration-time curve of BI 1569912 in plasma over a uniform dosing interval of 24 h after administration of the first dose (AUC0-24) is reported.
Measured: Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration.
Maximum Measured Concentration of BI 1569912 in Plasma After the First Dose (Cmax)
Maximum measured concentration of BI 1569912 in plasma after the first dose (Cmax) is reported.
Measured: Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration.
Area Under the Concentration-time Curve of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Last Dose
Area under the concentration-time curve of BI 1569912 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) after the last dose is reported.
Measured: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.
Maximum Measured Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Last Dose
Maximum measured concentration of BI 1569912 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) after the last dose is reported.
Measured: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.
Minimum Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss) After the Last Dose
Minimum concentration of BI 1569912 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) after the last dose is reported.
Measured: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.
Accumulation Ratio Based on Cmax,ss (RA,Cmax) After the Last Dose
Accumulation ratio based on Cmax,ss (RA,Cmax) after the last dose is reported. The BI 1569912 elderly 10/20 mg treatment group was not analysed for this endpoint because dose was changed on Day 1 and Day 14.
Measured: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14.
Accumulation Ratio Based on AUC0-τ (RA,AUC) After the Last Dose
Accumulation ratio based on AUC0-τ 0 to tau (RA,AUC) after the last dose is reported.
The BI 1569912 elderly 10/20 mg treatment group was not analysed for this endpoint because dose was changed on Day 1 and Day 14.
Measured: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14.

Timeline

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

3 Sep 20214 Jul 2024

First posted27 Jul 2021
Study start3 Sep 2021
Primary completion4 Jul 2024
Study completion4 Jul 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.
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
Masking: Single blind
Who is masked: Participant
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04978506
Sponsor's protocol ID: 1447-0002
Other IDs: 2021-001717-36
Status last verified: Jun 2026
First submitted: 26 Jul 2021
Last updated: 26 Jun 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, 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.mystudywindow.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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Oral Doses of BI 1569912 (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel Group Design) With an Optional Posology (Uptitration) Part (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel Group Design) in Healthy Male Subjects
ClinicalTrials.gov ID: NCT04978506
Acronym / sponsor ID: 1447-0002
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 3 Sep 2021 (actual)
Primary completion: 4 Jul 2024 (actual)
Study completion: 4 Jul 2024 (actual)
First posted: 27 Jul 2021 (actual)
Results: Posted 26 Jun 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: 9

Arm	Type	Receives
Placebo group for MRD part	Placebo comparator	Drug: PlaceboHealthy male subjects were administered placebo tablets matching the respective treatment group in the MRD part orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 or 340 milliliters (ml) of water.
Placebo for elderly treatment group	Placebo comparator	Drug: PlaceboElderly healthy male subjects were administered placebo tablets matching the elderly treatment group orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.
BI 1569912 2.5 mg treatment group (MRD)	Experimental	Drug: BI 1569912Healthy male subjects were administered BI 1569912 2.5 milligrams (mg) (1x2.5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
BI 1569912 5 mg treatment group (MRD)	Experimental	Drug: BI 1569912Healthy male subjects were administered BI 1569912 5 mg (1x5 mg tablet) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
BI 1569912 10 mg treatment group (MRD)	Experimental	Drug: BI 1569912Healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
BI 1569912 20 mg treatment group (MRD)	Experimental	Drug: BI 1569912Healthy male subjects were administered BI 1569912 20 mg (4x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
BI 1569912 30 mg treatment group (MRD)	Experimental	Drug: BI 1569912Healthy male subjects were administered BI 1569912 30 mg (6x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
BI 1569912 40 mg treatment group (MRD)	Experimental	Drug: BI 1569912Healthy male subjects were administered BI 1569912 40 mg (8x5 mg tablets) orally once daily over 14 days in the morning after an overnight fast of at least 10 hours together with 340 milliliters (ml) of water in the multiple rising dose (MRD) part of the study.
BI 1569912 elderly 10/20 mg treatment group	Experimental	Drug: BI 1569912Elderly healthy male subjects were administered BI 1569912 10 mg (2x5 mg tablets) orally once daily during study days 1 to 7 followed by 20 mg (4x5 mg tablets) orally once daily during study days 8 to 14 in the morning after an overnight fast of at least 10 hours together with 240 milliliters (ml) of water.

Who may qualify

Ages: 18 to 80 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older 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)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
MRD- and POSO-part: Age of 18 to 45 years (inclusive); ELDERLY-part: Age of 65 to 80 years (inclusive)
Body mass index (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 (8 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 millimetres of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 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
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	BI 1569912 10 mg treatment group (MRD), BI 1569912 2.5 mg treatment group (MRD), BI 1569912 20 mg treatment group (MRD), BI 1569912 30 mg treatment group (MRD), BI 1569912 40 mg treatment group (MRD), BI 1569912 5 mg treatment group (MRD), BI 1569912 elderly 10/20 mg treatment group
PlaceboPlacebo	Drug	Placebo for elderly treatment group, Placebo group for MRD part

Primary outcome

Number of Subjects With Drug-related Adverse Events
Time frame: Up to Day 27
Number of subjects with drug-related adverse events is reported.

7 secondary outcomes

Area Under the Concentration-time Curve of BI 1569912 in Plasma Over a Uniform Dosing Interval of 24 h After Administration of the First Dose (AUC0-24)
Time frame: Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration.
Maximum Measured Concentration of BI 1569912 in Plasma After the First Dose (Cmax)
Time frame: Within 3 hours before first drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 15 min, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, and 23 hrs after the first drug administration.
Area Under the Concentration-time Curve of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) After the Last Dose
Time frame: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.
Maximum Measured Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) After the Last Dose
Time frame: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.
Minimum Concentration of BI 1569912 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss) After the Last Dose
Time frame: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs, 47 hrs and 71 hrs after the last drug administration.
Accumulation Ratio Based on Cmax,ss (RA,Cmax) After the Last Dose
Time frame: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14.
Accumulation Ratio Based on AUC0-τ (RA,AUC) After the Last Dose
Time frame: Within 1 hour before last drug administration and at 15 minutes (min), 30 min, 45 min, 1 hour, 1 hour 30 min, 2 hours (hrs), 2 hrs 30 min, 3 hrs, 4 hrs, 6 hrs, 8 hrs, 10 hrs, 12 hrs, 23 hrs after the last administration on Day 1 and Day 14.

Results and safety

Results posted to the registry on 26 Jun 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
Placebo Group for MRD Part	17	16
Placebo for Elderly Treatment Group	3	3
BI 1569912 2.5 mg Treatment Group (MRD)	9	8
BI 1569912 5 mg Treatment Group (MRD)	9	8
BI 1569912 10 mg Treatment Group (MRD)	9	9
BI 1569912 20 mg Treatment Group (MRD)	9	9
BI 1569912 30 mg Treatment Group (MRD)	9	9
BI 1569912 40 mg Treatment Group (MRD)	9	8
BI 1569912 Elderly 10/20 mg Treatment Group	9	9

Primary outcome: Number of Subjects With Drug-related Adverse Events

Time frame: Up to Day 27. Count of participants. Unit: Participants

Measure	Placebo Group for MRD Part n = 17	Placebo Elderly Treatment Group n = 3	BI 1569912 2.5 mg Treatment Group (MRD) n = 9	BI 1569912 5 mg Treatment Group (MRD) n = 9	BI 1569912 10 mg Treatment Group (MRD) n = 9	BI 1569912 20 mg Treatment Group (MRD) n = 9	BI 1569912 30 mg Treatment Group (MRD) n = 9	BI 1569912 40 mg Treatment Group (MRD) n = 9	BI 1569912 Elderly 10/20 mg Treatment Group n = 9
Value	1	0	2	1	0	2	1	4	0

Population analysed: Treated set (TS): The treated set includes all subjects who were randomized and treated with at least one dose of study drug. The treatment assignment was determined based on the first treatment the subjects received. The treated set was used for safety analyses.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: For all on-treatment AEs: From start of drug administration till last day of drug administration + residual effect period, up to 14 days + 36 hours. For all-cause mortality: From start of drug administration till end of follow-up period, up to 27 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Group for MRD Part	0 of 17 (0%)	3 of 17 (17.6%)	0 of 17
Placebo for Elderly Treatment Group	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
BI 1569912 2.5 mg Treatment Group (MRD)	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
BI 1569912 5 mg Treatment Group (MRD)	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
BI 1569912 10 mg Treatment Group (MRD)	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
BI 1569912 20 mg Treatment Group (MRD)	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
BI 1569912 30 mg Treatment Group (MRD)	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
BI 1569912 40 mg Treatment Group (MRD)	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
BI 1569912 Elderly 10/20 mg Treatment Group	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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.mystudywindow.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 8 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 26 Jun 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 26 Jun 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?

Number of Subjects With Drug-related Adverse Events (time frame: Up to Day 27). 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 NCT04978506, 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 26 Jun 2026.