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

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

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.

Sponsors & Collaborators

• Eisai Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-10-05

Primary Completion

2012-08-11

Completion

2012-08-11

FDA Drug

Yes

Countries

• United States

Study Locations