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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 3731579 in Healthy Volunteers (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

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Trial Profile

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 3731579 in Healthy Volunteers (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 20 Aug 2026

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At a glance

  • Drugs BI 3731579 (Primary) ; Midazolam (Primary)
  • Indications Unspecified
  • Focus Adverse reactions
  • Sponsors Boehringer Ingelheim; Boehringer Ingelheim GmbH International

Most Recent Events

  • 10 Aug 2026 Arms decreased from 5 to 4. Timeframe for primary endpoint changed from ' up to Day 27' to 'From first drug administration on Day 2 until last drug administration on Day 17, plus residual effect period (REP) for each intervention. Up to 19 days.'
  • 17 Mar 2026 Actual primary completion date changed from 5 Jun 2025 to 19 May 2025.
  • 17 Jul 2025 Status changed from recruiting to discontinued.

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