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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1569912 in Healthy Male Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design) With an Additional Relative Bioavailability/ Food Effect Part (Open-label, Randomized, Three-way Crossover Design)

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Trial Profile

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1569912 in Healthy Male Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design) With an Additional Relative Bioavailability/ Food Effect Part (Open-label, Randomized, Three-way Crossover Design)

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 25 Nov 2022

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At a glance

  • Drugs BI 1569912 (Primary)
  • Indications Major depressive disorder
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Boehringer Ingelheim

Most Recent Events

  • 18 Oct 2022 Results (n=55) assessing safety, tolerability and pharmacokinetics (PK) of single rising doses (SRD) of BI 1569912 in healthy volunteers presented at the 35th Annual Congress of the European College of Neuropsychopharmacology
  • 18 Oct 2022 Results(n=55) assessing exploratory findings on the utility of electroencephalography (EEG) and eye-tracking parameters as treatment response biomarkers for central target engagement by BI 1569912 presented at the 35th Annual Congress of the European College of Neuropsychopharmacology
  • 11 Nov 2021 Status changed from suspended to discontinued due to identification of potential mutagenic metabolite in human plasma.

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