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Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1358894 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 1358894 (Open-label, Randomised, Two-way Cross-over)

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Trial Profile

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1358894 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 1358894 (Open-label, Randomised, Two-way Cross-over)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 27 Mar 2025

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At a glance

  • Drugs BI 1358894 (Primary)
  • Indications Major depressive disorder
  • Focus Adverse reactions
  • Sponsors Boehringer Ingelheim

Most Recent Events

  • 15 Sep 2020 Results evaluating safety and pharmacokinetics of oral BI 1358894 in healthy male volunteers, presented at the 33rd Annual Congress of the European College of Neuropsychopharmacology
  • 19 Feb 2019 Status changed from active, no longer recruiting to completed.
  • 12 Feb 2019 Planned End Date changed from 6 Feb 2019 to 15 Feb 2019.

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