NCT01463098

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

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: Phase 1
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	E2006 1.0 mg	E2006 1.0 mg capsule.
DRUG	E2006 2.5 mg	E2006 2.5 mg capsule.
DRUG	E2006 5.0 mg	E2006 5.0 mg (2 capsules of 2.5 mg each).
DRUG	E2006 10.0 mg	E2006 10.0 mg capsule.
DRUG	E2006 25.0 mg	E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each).
DRUG	E2006 50.0 mg	E2006 50.0 mg capsule.
DRUG	E2006 100 mg	E2006 100 mg (2 capsules of 50 mg each).
DRUG	E2006 200 mg	E2006 200 mg (4 capsules of 50 mg each).
DRUG	Zolpidem 10 mg	Zolpidem 10 mg immediate release tablet.
DRUG	E2006 Matched Placebo or Zolpidem Matched Placebo	E2006-matched placebo capsules or zolpidem-matched placebo tablets.
DRUG	E2006 Matched Placebo	E2006-matched placebo capsule.

Timeline

• Start date: 2011-10-05
• Primary completion: 2012-08-11
• Completion: 2012-08-11
• First posted: 2011-11-01
• Last updated: 2020-01-18
• Results posted: 2020-01-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study