HealthyPhase 1NCT04958252

A Study in Healthy Japanese Men to Test How Different Doses of BI 1569912 Are Taken up by the Body and How Well They Are Tolerated

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

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 safety and tolerability of BI 1569912 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses. Secondary objective is the exploration of pharmacokinetics (PK) 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: 56 participants
Where: 1 siteJapan
Study dates: 5 Aug 2021to 30 Oct 2023
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 medical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
Age of 18 to 45 years (inclusive)
Body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication

Show all 9Show fewer

Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration.
Vasectomized (vasectomy at least 1 year prior to enrolment)
Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner

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 40 to 90 mmHg, or pulse rate outside the range of 40 to 99 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
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 or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

Japan1 site

SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, 130-0004

Other trials in Japan

About this study

Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1569912 in Healthy Male Japanese Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design)

The main objectives of this trial are to investigate safety and tolerability of BI 1569912 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.

Secondary objective is the exploration of pharmacokinetics (PK) of BI 1569912.

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 NCT04958252
Study group	Role	What they receive
Single-rising dose part - BI 1569912 2.5 mg	Experimental	Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours. Receives: Drug: BI 1569912
Single-rising dose part - BI 1569912 5 mg	Experimental	Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours. Receives: Drug: BI 1569912
Single-rising dose part - BI 1569912 10 mg	Experimental	Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. Receives: Drug: BI 1569912
Single-rising dose part - BI 1569912 20 mg	Experimental	Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. Receives: Drug: BI 1569912
Multiple dose part - 20 mg BI 1569912	Experimental	Healthy male subjects were administered one daily dose of 20 milligram (mg) of BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days. Receives: Drug: BI 1569912
Multiple dose part - Placebo	Placebo comparator	Healthy male subjects were administered one daily matching dose of placebo as tablets orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days. Receives: Drug: Placebo
Evening pharmacokinetics part I - 5 mg BI 1569912 T-R	Experimental	Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the evening (test treatment (T)) orally with 240 milliliters (mL) of water after a fasting period of at least 5 hours (h). After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the morning (reference treatment (R)) orally with 240 mL of water after an overnight fast of at least 10 h. Receives: Drug: BI 1569912
Evening pharmacokinetics part II - 5 mg BI 1569912 R-T	Experimental	Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the morning (reference treatment (R)) orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the evening (test treatment (T)) orally with 240 mL of water after a fasting period of at least 5 h. Receives: Drug: BI 1569912
Single-rising dose part - Placebo	Placebo comparator	Subjects treated with placebo were assigned to each dose group (DG) of the SRD part, and are all included in this arm, regardless of the DGs they were part of. Healthy male subjects were administered one dose of matching placebo orally as one or multiple tablets, depending on the DG they were assigned to, with 240 milliliters of water after an overnight fast of at least 10 hours. Receives: Drug: Placebo

What is being measured

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

SRD Part - Number of Subjects With Drug-related Adverse Events
Number of subjects in the single-rising dose (SRD) part with drug-related adverse events (AEs) is reported.
Measured: From drug administration plus 48 hours (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.
MD Part - Number of Subjects With Drug-related Adverse Events
Number of subjects in the multiple dose (MD) part with drug-related adverse events is reported.
Measured: From first drug administration until last administration of study drug plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days.
Evening PK 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)
Evening pharmacokinetics (PK) 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) is reported.
Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale.
Measured: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.
Evening PK Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Evening pharmacokinetics (PK) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported.
Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale.
Measured: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.

Secondary outcomes (8)

Evening PK Part - Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Evening pharmacokinetics (PK) part - area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale.
Measured: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.
SRD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Single-rising dose (SRD) part - area under the concentration-time curve of BI 1569912 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.
Measured: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration.
SRD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Single-rising dose (SRD) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported.
Measured: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration.
MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma From 0 to 24 h (AUC0-24) After the First Dose
Multiple dose (MD) part - area under the concentration-time curve of BI 1569912 in plasma from 0 to 24 hours (h) (AUC0-24) after the first dose is reported. AUC0-24 was calculated by extrapolation
Measured: Within 3 h prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration.
MD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax) After the First Dose
Multiple dose (MD) part - maximum measured concentration of BI 1569912 in plasma (Cmax) after the first dose is reported.
Measured: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration.
MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Dosing Interval τ at Steady State (AUCτ,ss) After the Last Dose
Multiple dose (MD) part - area under the concentration-time curve of BI 1569912 in plasma over the dosing interval τ at steady state (AUCτ,ss) after the last dose is reported. The dosing interval τ is 24 hours (h).
Measured: One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration.
MD Part - Maximum Measured Concentration of BI 1569912 in Plasma at Steady State (Cmax,ss) After the Last Dose
Multiple dose (MD) part - maximum measured concentration of BI 1569912 in plasma at steady state (Cmax,ss) after the last dose is reported.
Measured: One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration.
Evening PK Part - Number of Subjects With Drug-related Adverse Events
Number of subjects in the evening pharmacokinetics (PK) part with drug-related adverse events is reported.
Measured: From drug administration plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.

Timeline

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

5 Aug 202130 Oct 2023

First posted12 Jul 2021
Study start5 Aug 2021
Primary completion30 Oct 2023
Study completion30 Oct 2023

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: Crossover
Model description: The single-rising dose part and multiple dose part of the trial is designed as single-blind, partially randomised, and placebo-controlled within parallel dose groups. The evening pharmacokinetics part is designed as a randomised, two-sequence, open-label, two period, two-way cross over trial.
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04958252
Sponsor's protocol ID: 1447-0004
Status last verified: Apr 2026
First submitted: 6 Jul 2021
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, 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?

See locations

Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy

All Healthy trials

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 and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1569912 in Healthy Male Japanese Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design)
ClinicalTrials.gov ID: NCT04958252
Acronym / sponsor ID: 1447-0004
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 5 Aug 2021 (actual)
Primary completion: 30 Oct 2023 (actual)
Study completion: 30 Oct 2023 (actual)
First posted: 12 Jul 2021 (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 safety and tolerability of BI 1569912 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.

Secondary objective is the exploration of pharmacokinetics (PK) of BI 1569912.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 9
Model description: The single-rising dose part and multiple dose part of the trial is designed as single-blind, partially randomised, and placebo-controlled within parallel dose groups. The evening pharmacokinetics part is designed as a randomised, two-sequence, open-label, two period, two-way cross over trial.

Arm	Type	Receives
Single-rising dose part - BI 1569912 2.5 mg	Experimental	Drug: BI 1569912Healthy male subjects were administered one tablet of 2.5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
Single-rising dose part - BI 1569912 5 mg	Experimental	Drug: BI 1569912Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 orally with 240 milliliters of water after an overnight fast of at least 10 hours.
Single-rising dose part - BI 1569912 10 mg	Experimental	Drug: BI 1569912Healthy male subjects were administered one dose of 10 milligram (mg) BI 1569912 (2 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
Single-rising dose part - BI 1569912 20 mg	Experimental	Drug: BI 1569912Healthy male subjects were administered one dose of 20 milligram (mg) BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours.
Multiple dose part - 20 mg BI 1569912	Experimental	Drug: BI 1569912Healthy male subjects were administered one daily dose of 20 milligram (mg) of BI 1569912 (4 tablets of 5 mg) orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days.
Multiple dose part - Placebo	Placebo comparator	Drug: PlaceboHealthy male subjects were administered one daily matching dose of placebo as tablets orally with 240 milliliters of water after an overnight fast of at least 10 hours. The treatment was administered for 14 days.
Evening pharmacokinetics part I - 5 mg BI 1569912 T-R	Experimental	Drug: BI 1569912Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the evening (test treatment (T)) orally with 240 milliliters (mL) of water after a fasting period of at least 5 hours (h). After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the morning (reference treatment (R)) orally with 240 mL of water after an overnight fast of at least 10 h.
Evening pharmacokinetics part II - 5 mg BI 1569912 R-T	Experimental	Drug: BI 1569912Healthy male subjects were administered one tablet of 5 milligram (mg) BI 1569912 in the morning (reference treatment (R)) orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h). After a washout period of at least 5 days, subjects were administered one tablet of 5 mg BI 1569912 in the evening (test treatment (T)) orally with 240 mL of water after a fasting period of at least 5 h.
Single-rising dose part - Placebo	Placebo comparator	Drug: PlaceboSubjects treated with placebo were assigned to each dose group (DG) of the SRD part, and are all included in this arm, regardless of the DGs they were part of. Healthy male subjects were administered one dose of matching placebo orally as one or multiple tablets, depending on the DG they were assigned to, with 240 milliliters of water after an overnight fast of at least 10 hours.

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 medical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
Age of 18 to 45 years (inclusive)
Body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

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 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 to 99 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
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	Evening pharmacokinetics part I - 5 mg BI 1569912 T-R, Evening pharmacokinetics part II - 5 mg BI 1569912 R-T, Multiple dose part - 20 mg BI 1569912, Single-rising dose part - BI 1569912 10 mg, Single-rising dose part - BI 1569912 2.5 mg, Single-rising dose part - BI 1569912 20 mg, Single-rising dose part - BI 1569912 5 mg
PlaceboPlacebo	Drug	Multiple dose part - Placebo, Single-rising dose part - Placebo

Primary outcome

SRD Part - Number of Subjects With Drug-related Adverse Events
Time frame: From drug administration plus 48 hours (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.
Number of subjects in the single-rising dose (SRD) part with drug-related adverse events (AEs) is reported.
MD Part - Number of Subjects With Drug-related Adverse Events
Time frame: From first drug administration until last administration of study drug plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days.
Number of subjects in the multiple dose (MD) part with drug-related adverse events is reported.
Evening PK 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 to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.
Evening pharmacokinetics (PK) 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) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale.
Evening PK Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Time frame: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.
Evening pharmacokinetics (PK) part - maximum measured concentration of BI 1569912 in plasma (Cmax) is reported. Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: the effect 'subjects within sequences' was considered as random, whereas 'sequence', 'period', and 'treatment' were considered as fixed. These quantities were then back-transformed to the original scale.

8 secondary outcomes

Evening PK Part - Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.
SRD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration.
SRD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)
Time frame: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 h after drug administration.
MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma From 0 to 24 h (AUC0-24) After the First Dose
Time frame: Within 3 h prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration.
MD Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax) After the First Dose
Time frame: Within 3 hours (h) prior to drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23 h after first drug administration.
MD Part - Area Under the Concentration-time Curve of BI 1569912 in Plasma Over the Dosing Interval τ at Steady State (AUCτ,ss) After the Last Dose
Time frame: One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration.
MD Part - Maximum Measured Concentration of BI 1569912 in Plasma at Steady State (Cmax,ss) After the Last Dose
Time frame: One hour (h) prior to the last drug administration and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 23, 47, 71 h after last drug administration.
Evening PK Part - Number of Subjects With Drug-related Adverse Events
Time frame: From drug administration plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.

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
Single-rising Dose Part - Placebo	8	8
Single-rising Dose Part - BI 1569912 2.5 mg	6	6
Single-rising Dose Part - BI 1569912 5 mg	6	6
Single-rising Dose Part - BI 1569912 10 mg	6	6
Single-rising Dose Part - BI 1569912 20 mg	6	6
Multiple Dose Part - Placebo	3	3
Multiple Dose Part - 20 mg BI 1569912	9	9
Evening Pharmacokinetics Part I - 5 mg BI 1569912 T-R	6	6
Evening Pharmacokinetics Part II - 5 mg BI 1569912 R-T	6	6

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

Time frame: From drug administration plus 48 hours (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.. Count of participants. Unit: Participants

Measure	SRD Part - Placebo n = 8	Single-rising Dose Part - BI 1569912 2.5 mg n = 6	Single-rising Dose Part - BI 1569912 5 mg n = 6	Single-rising Dose Part - BI 1569912 10 mg n = 6	Single-rising Dose Part - BI 1569912 20 mg n = 6
Value	0	0	0	0	0

Population analysed: Treated set (TS) restricted to the SRD part included all SRD subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received.

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

Time frame: From first drug administration until last administration of study drug plus 48 hours (REP), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days.. Count of participants. Unit: Participants

Measure	Multiple Dose Part - Placebo n = 3	Multiple Dose Part - 20 mg BI 1569912 n = 9
Value	1	2

Population analysed: Treated set restricted to the MD part included all MD subjects who were randomised and treated with any dose of BI 1569912 or placebo. The treatment assignment was determined based on the first treatment the subjects received.

Primary outcome: Evening PK 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 to drug administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 h after drug administration.. Geometric least squares mean (Standard Error). Unit: hours*nanomole/Liter

Measure	Evening Pharmacokinetics Part - 5 mg BI 1569912 R n = 12	Evening Pharmacokinetics Part - 5 mg BI 1569912 T n = 12
Value	892.68 (NA)	817.93 (NA)

Evening Pharmacokinetics Part - 5 mg BI 1569912 R vs Evening Pharmacokinetics Part - 5 mg BI 1569912 T: Ratio of adjusted geometric means [%]: 91.63 (90% CI 89.46 to 93.84)

Population analysed: Pharmacokinetic parameter evening analysis set (PKS-E) included all subjects in the TS of the evening PK part who provided at least 1 primary or secondary PK endpoint value that was not excluded due to a protocol deviation relevant to the statistical evaluation of PK or due to PK non-evaluability. A subject was included in the PKS-E even if he contributed only 1 PK parameter value for one of the 2 periods to the statistical assessment.

Primary outcome: Evening PK Part - Maximum Measured Concentration of BI 1569912 in Plasma (Cmax)

Measure	Evening Pharmacokinetics Part - 5 mg BI 1569912 R n = 12	Evening Pharmacokinetics Part - 5 mg BI 1569912 T n = 12
Value	372.78 (NA)	246.01 (NA)

Evening Pharmacokinetics Part - 5 mg BI 1569912 R vs Evening Pharmacokinetics Part - 5 mg BI 1569912 T: Ratio of adjusted geometric means [%]: 65.99 (90% CI 53.36 to 81.61)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Single-rising dose (SRD) & evening pharmacokinetics (PK): from drug intake plus 48 hours (h) (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 h. Multiple dose (MD): from first drug intake until last intake of study drug plus REP, or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 16 days. All-cause mortality: up to 14 (SRD), 27 (MD) and 13 (evening PK) days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-rising Dose Part - Placebo	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Single-rising Dose Part - BI 1569912 2.5 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Single-rising Dose Part - BI 1569912 5 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Single-rising Dose Part - BI 1569912 10 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Single-rising Dose Part - BI 1569912 20 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Multiple Dose Part - Placebo	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Multiple Dose Part - 20 mg BI 1569912	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
Evening Pharmacokinetics Part - 5 mg BI 1569912 R	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Evening Pharmacokinetics Part - 5 mg BI 1569912 T	0 of 12 (0%)	0 of 12 (0%)	0 of 12

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.mystudywindow.com/msw/datasharing

Related trials for Healthy

Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy

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 Japan.

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 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 Japan. 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?

SRD Part - Number of Subjects With Drug-related Adverse Events (time frame: From drug administration plus 48 hours (residual effect period (REP)), or 12:00 a.m. on day after subject's trial termination date, whichever occurs first, up to 48 hours.). 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 NCT04958252, 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.