A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006

Completed · Phase 1 · Has a placebo group

Conditions studied: Insomnia

In brief

Part A: The purpose of this study is to evaluate the safety and tolerability of single oral doses of E2006 administered in the morning to healthy male and female subjects. Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects with primary insomnia following single oral dosing of E2006 in the evening approximately 30 minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.

Key facts

Study ID
NCT01463098
Run by
Eisai Inc.
People needed
122
Starts
2011-10-05
Expected to finish
2012-08-11
Last updated by the study team
2020-01-18

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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