NCT02362516 is a Phase 1 clinical trial of BI 425809 in Healthy, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT02362516?

NCT02362516 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT02362516?

Interventions in NCT02362516: BI 425809.

Is NCT02362516 still recruiting?

NCT02362516 is currently completed. Last updated 30 March 2026.

Are results published for NCT02362516?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-03-30 · How we verify

NCT02362516

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

Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809

Completed Phase 1 Results posted Last updated 30 March 2026

What this trial tests

Phase 1 trial testing BI 425809 in Healthy in 25 participants. Completed in 19 June 2015.

Timeline

23 February 2015

Primary endpoint
19 June 2015

19 June 2015

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	23 February 2015
Primary completion	19 June 2015
Estimated completion	19 June 2015
Sites	1 location across Belgium

Drugs / interventions tested

BI 425809 — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 55, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14) Primary · 0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.

Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 14h (AUC0-14).

Group	Value	95% CI
BI 425809 5 mg	421.0	± 17.6
BI 425809 10 mg	829	± 18.9
BI 425809 25 mg	1840.0	± 24.2
BI 425809 50 mg	3300.0	± 29.3

Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14) Primary · 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.

Area under the concentration-time curve of BI 425809 in cerebrospinal fluid (CSF) over the time interval from 0 to 14h (AUC0-14).

Group	Value	95% CI
BI 425809 5 mg	29.9	± 15.4
BI 425809 10 mg	59.8	± 19.3
BI 425809 25 mg	124.0	± 27.2
BI 425809 50 mg	260.0	± 29.1

Maximum Measured Concentration of BI 425809 in Plasma (Cmax) Primary · Up to 17 days (for detailed timeframe please see description).

Maximum measured concentration of BI 425809 in plasma is reported. Time Frame: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h, 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h, 312:00h and 312:30h, 313:00h, 314:00h, 315:00h, 315:30h, 316:00h, 316:30h, 317:00h, 318:00h, 320:00h, 322:00h, 324:00h, 336:00h, 360:00h, 384:00h after first administration of BI 425809.

Group	Value	95% CI
BI 425809 5 mg	42.3	± 23.2
BI 425809 10 mg	85.6	± 19.5
BI 425809 25 mg	176	± 22.6
BI 425809 50 mg	328	± 37.5

Maximum Measured Concentration of BI 425809 in CSF (Cmax) Primary · 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.

Maximum measured concentration of BI 425809 in CSF is reported.

Group	Value	95% CI
BI 425809 5 mg	2.91	± 21.3
BI 425809 10 mg	5.59	± 17.5
BI 425809 25 mg	12.2	± 26.4
BI 425809 50 mg	25.0	± 37.5

Concentration of BI 425809 in Plasma at the Time Point 312h (C312) Primary · 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h and 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h and 312:00h after first administration of BI 425809.

Concentration of BI 425809 in plasma at the time point 312h (C312) is reported.

Group	Value	95% CI
BI 425809 5 mg	66.7	± 40.9
BI 425809 10 mg	107	± 48.2
BI 425809 25 mg	266	± 38.4
BI 425809 50 mg	445	± 50.3

Concentration of BI 425809 in CSF at the Time Point 312h (C312) Primary · 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.

Concentration of BI 425809 in CSF at the time point 312h (C312) is reported.

Group	Value	95% CI
BI 425809 5 mg	5.62	± 51.8
BI 425809 10 mg	9.67	± 41.9
BI 425809 25 mg	21.7	± 33.2
BI 425809 50 mg	42.4	± 36.7

Percentage of Participants With Drug-related Adverse Events (AEs) Secondary · From the first drug administration until 11 days after the last drug administration, up to 30days.

Percentage of participants with drug-related adverse events (AEs).

Group	Value	95% CI
BI 425809 5 mg	0
BI 425809 10 mg	0
BI 425809 25 mg	12.5
BI 425809 50 mg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first drug administration until 11 days after the last drug administration, up to 30 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BI 425809 5 mg

Serious: 0/6 (0%)

Deaths: —

BI 425809 10 mg

Serious: 0/6 (0%)

Deaths: —

BI 425809 25 mg

Serious: 0/8 (0%)

Deaths: —

BI 425809 50 mg

Serious: 0/5 (0%)

Deaths: —

Other adverse events (25 terms — click to expand)

Reaction	System	BI 425809 5 mg	BI 425809 10 mg	BI 425809 25 mg	BI 425809 50 mg
Procedural headache	Injury, poisoning and procedural complications	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Gingivitis	Infections and infestations	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—
Tension headache	Nervous system disorders	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—
Flushing	Vascular disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Catheter site pain	General disorders	—	—	—	—
Wound	Injury, poisoning and procedural complications	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—

Data from ClinicalTrials.gov NCT02362516 adverse events section.

Sponsor's own description

To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Development of the novel GlyT1 inhibitor, iclepertin (BI 425809), for the treatment of cognitive impairment associated with schizophrenia.
Rosenbrock H, Desch M, Wunderlich G. · · 2023 · cited 56× · PMID 36971864 · DOI 10.1007/s00406-023-01576-z
Evaluation of Pharmacokinetics and Pharmacodynamics of BI 425809, a Novel GlyT1 Inhibitor: Translational Studies.
Rosenbrock H, Desch M, Kleiner O, Dorner-Ciossek C, et al · · 2018 · cited 32× · PMID 30136756 · DOI 10.1111/cts.12578
Pharmacological Treatment of Cognitive Impairment Associated With Schizophrenia: State of the Art and Future Perspectives.
Vita A, Nibbio G, Barlati S. · · 2024 · cited 13× · PMID 39144119 · DOI 10.1093/schizbullopen/sgae013

Verify or expand the search:

Other trials of BI 425809

Trials testing the same drug.

NCT05723874 — A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood · Phase 1 · completed
NCT05718843 — A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems · Phase 1 · completed
NCT05613777 — A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood · Phase 1 · completed
NCT05347004 — A Study in Healthy People to Test How BI 425809 is Taken up in the Body When Taken With or Without Food · Phase 1 · completed
NCT05076409 — A Study in Healthy Men to Test How Fluconazole Influences the Amount of BI 425809 in the Blood · 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 NCT02362516 (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: 30 March 2026

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/NCT02362516.

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

NCT02362516

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of BI 425809

Other recruiting trials for Healthy

Other Boehringer Ingelheim trials

Verify against primary sources