21 completed, 1 terminated. 18 Phase 1, 3 Phase 3, 1 Phase 2.
By phase and status
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix .
Trial Phase Status Sponsor Enrollment Start Updated
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems Iclepertin - Hepatic Insufficiency Phase 1 Completed 29 2023-03-08 2026-04-24 A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood BI 425809, Bosentan - Healthy Phase 1 Completed 14 2023-03-06 2026-03-30 A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems BI 425809 - Renal Insufficiency Phase 1 Completed 36 2023-02-01 2026-03-30 A Study in Healthy Women to Test Whether BI 425809 Influences the Amount of a Contraceptive in the Blood Microgynon®, Iclepertin - Healthy Phase 1 Completed 19 2022-11-24 2026-05-06 A Study in Healthy People to Test How BI 425809 is Taken up in the Body When Taken With or Without Food BI 425809 - Healthy Phase 1 Completed 16 2022-10-25 2026-04-20 A Study to Test Long-term Safety of Iclepertin in People With Schizophrenia Who Took Part in a Previous CONNEX Study Iclepertin - Schizophrenia Phase 3 Terminated 1356 2022-03-21 2026-04-08 A Study in Healthy Men to Test Whether BI 425809 Influences the Amount of Midazolam in the Blood midazolam, iclepertin (BI 425809) - Healthy Phase 1 Completed 15 2022-03-18 2026-03-30 A Study in Healthy Men to Test How Fluconazole Influences the Amount of BI 425809 in the Blood BI 425809, fluconazole - Healthy Phase 1 Completed 15 2021-10-19 2026-05-04 Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2) Iclepertin, Placebo - Schizophrenia Phase 3 Completed 611 2021-08-24 2025-12-12 CONNEX-3: A Study to Test Whether Iclepertin Improves Learning and Memory in People With Schizophrenia Iclepertin, Placebo - Schizophrenia Phase 3 Completed 609 2021-08-09 2026-02-06 A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine Lamotrigine, BI 409306, Placebo - Healthy Phase 1 Completed 40 2020-12-01 2024-03-12 A Study in Healthy Men and Women to Test Which Effects Memantine and BI 425809 Have on Each Other BI 425809, Memantine - Healthy Phase 1 Completed 16 2019-07-17 2021-04-13 This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia BI 425809, Placebo - Schizophrenia Phase 2 Completed 200 2019-04-15 2023-11-18 A Study in Healthy Men and Women to Test Which Effects Donepezil and BI 425809 Have on Each Other BI 425809, Donepezil - Healthy Phase 1 Completed 32 2019-04-12 2021-02-17 A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a Tablet BI 425809, [C-14]-BI 425809 - Healthy Phase 1 Completed 6 2019-01-15 2026-03-27 A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 425809 in the Blood Rifampicin, BI 425809 - Healthy Phase 1 Completed 16 2017-03-28 2026-03-30 Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin Midazolam, Warfarin, Omeprazole - Healthy Phase 1 Completed 13 2015-09-07 2026-04-15 Single Rising Dose Trial of BI 425809 for Healthy Japanese and Chinese Male Subjects BI 425809, Placebo - Healthy Phase 1 Completed 49 2015-05-11 2026-03-30 Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809 BI 425809 - Healthy Phase 1 Completed 25 2015-02-23 2026-05-01 Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects BI 425809, Itraconazole - Healthy Phase 1 Completed 16 2015-01-29 2026-10-02
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Conditions studied Schizophrenia (4) · Hepatic Insufficiency (1) · Renal Insufficiency (1)
Sponsors Boehringer Ingelheim (22)
Countries Germany (16) · United States (5) · South Korea (4) · Argentina (3) · Belgium (3) · Brazil (3) · France (3) · Netherlands (3) · Serbia (3) · United Kingdom (3) · Australia (2) · Austria (2) · Bulgaria (2) · Canada (2) · Chile (2)
Results publications PMID 34716565 , PMID 41233083 , PMID 41903096 , PMID 29076028 , PMID 29846887 , PMID 31005336 , PMID 32036587 , PMID 34936055 , PMID 36700734 , PMID 39759424 , PMID 40676451 , PMID 40906309
NIH funding 2014 (3) , 2018 (3) , 2015 (1) , 2016 (1) , 2019 (1)