NCT04958252 is a Phase 1 clinical trial of BI 1569912 in Healthy, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT04958252?

NCT04958252 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT04958252?

Interventions in NCT04958252: BI 1569912, Placebo.

Is NCT04958252 still recruiting?

NCT04958252 is currently status unknown. Last updated 19 October 2023.

Last reviewed 2023-10-19 · How we verify

NCT04958252

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 1 Last updated 19 October 2023

What this trial tests

Phase 1 trial testing BI 1569912 in Healthy in 56 participants. Status unknown.

Timeline

5 August 2021

Primary endpoint
24 October 2023

24 October 2023

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	5 August 2021
Primary completion	24 October 2023
Estimated completion	24 October 2023
Sites	1 location across Japan

Drugs / interventions tested

BI 1569912 — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 45, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety and Efficacy of the NMDA-2b-Selective Negative Allosteric Modulator BI 1569912: A Phase Ib Randomized Trial in Major Depressive Disorder.
McIntyre RS, Sanacora G, Walling DP, Cohen EA, et al · · 2025 · PMID 40810366 · DOI 10.1002/cpt.70018

Verify or expand the search:

Other trials of BI 1569912

Trials testing the same drug.

NCT06558344 — A Study to Test Different Doses of BI 1569912 in People With Depression · Phase 2 · completed
NCT06367153 — A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropio · Phase 1 · completed
NCT06280235 — A Study to Test Different Doses of BI 1569912 in People With Depression Who Take Anti-depressive Medicine · Phase 2 · completed
NCT04978506 — A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated · Phase 1 · completed
NCT04937829 — A Study to Test How Well Different Doses of BI 1569912 Are Tolerated and How Well They Work in People With Depression Wh · Phase 1 · completed

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04958252 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 19 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04958252.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing