At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating E2006 1.0 mg, E2006 2.5 mg, and 9 other interventions for Insomnia. Completed, enrolled 122 participants across 2 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
E2006 1.0 mg capsule.
E2006 2.5 mg capsule.
E2006 5.0 mg (2 capsules of 2.5 mg each).
E2006 10.0 mg capsule.
E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each).
E2006 50.0 mg capsule.
E2006 100 mg (2 capsules of 50 mg each).
E2006 200 mg (4 capsules of 50 mg each).
Zolpidem 10 mg immediate release tablet.
E2006-matched placebo capsules or zolpidem-matched placebo tablets.
E2006-matched placebo capsule.