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Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-541468: Part A: Multiple-ascending Doses in Healthy Young Adults After Morning Administration Part B: Single-ascending Doses in Healthy Elderly Subjects After Morning Administration Part C: Repeated Doses in Both Healthy Young Adults and Elderly Subjects After Evening Administration

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Trial Profile

Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-541468: Part A: Multiple-ascending Doses in Healthy Young Adults After Morning Administration Part B: Single-ascending Doses in Healthy Elderly Subjects After Morning Administration Part C: Repeated Doses in Both Healthy Young Adults and Elderly Subjects After Evening Administration

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Feb 2021

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At a glance

  • Drugs Daridorexant (Primary)
  • Indications Insomnia
  • Focus Adverse reactions
  • Sponsors Actelion Pharmaceuticals

    • Most Recent Events

    • 17 Jun 2019 Results published in the European Neuropsychopharmacology
    • 12 Jun 2019 According to an Idorsia Pharmaceuticals media release, results assessing the effect of ACT-541468 in elderly subjects were presented at SLEEP 2019 (in San Antonio,Texas, USA).
    • 29 Feb 2016 Status changed from recruiting to completed, according to ClinicalTrials.gov record.

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