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A 2-Part, Randomized, Double-blind, Placebo- and Active- Controlled, Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Subjects and Otherwise Healthy Subjects With Primary Insomnia

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Trial Profile

A 2-Part, Randomized, Double-blind, Placebo- and Active- Controlled, Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Subjects and Otherwise Healthy Subjects With Primary Insomnia

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Lemborexant (Primary) ; Zolpidem
  • Indications Insomnia
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Sponsors Eisai Inc

    • Most Recent Events

    • 01 Jan 2021 Results assessing potential of lemborexant for residual morning and next-day effects, including somnolence from 9 studies (E2006-A001-001 Part B, E2006-A001-002, E2006-A001-003, E2006-E044-106, E2006-A001-107, E2006-A001-108, E2006-G000-201, E2006-G000-303 & E2006-G000-304) published in the Postgraduate Medicine.
    • 18 Dec 2012 Planned End Date changed from 1 Aug 2012 to 1 Jan 2013 as reported by ClinicalTrials.gov.
    • 18 Dec 2012 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.

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