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

NCT ID: NCT01463098

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-05
• Study Completion Date: 2012-08-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Part A: E2006 1.0 mg

Group Type: EXPERIMENTAL

E2006 1.0 mg

Intervention Type: DRUG

E2006 1.0 mg capsule.

Part A: E2006 2.5 mg

Group Type: EXPERIMENTAL

E2006 2.5 mg

Intervention Type: DRUG

E2006 2.5 mg capsule.

Part A: E2006 5.0 mg

Group Type: EXPERIMENTAL

E2006 5.0 mg

Intervention Type: DRUG

E2006 5.0 mg (2 capsules of 2.5 mg each).

Part A: E2006 10.0 mg

Group Type: EXPERIMENTAL

E2006 10.0 mg

Intervention Type: DRUG

E2006 10.0 mg capsule.

Part A: E2006 25.0 mg

Group Type: EXPERIMENTAL

E2006 25.0 mg

Intervention Type: DRUG

E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each).

Part A: E2006 50.0 mg

Group Type: EXPERIMENTAL

E2006 50.0 mg

Intervention Type: DRUG

E2006 50.0 mg capsule.

Part A: E2006 100 mg

Group Type: EXPERIMENTAL

E2006 100 mg

Intervention Type: DRUG

E2006 100 mg (2 capsules of 50 mg each).

Part A: E2006 200 mg

Group Type: EXPERIMENTAL

E2006 200 mg

Intervention Type: DRUG

E2006 200 mg (4 capsules of 50 mg each).

Part B: Zolpidem 10 mg

Group Type: EXPERIMENTAL

Zolpidem 10 mg

Intervention Type: DRUG

Zolpidem 10 mg immediate release tablet.

Part B: E2006 Matched Placebo or Zolpidem Matched Placebo

Group Type: EXPERIMENTAL

E2006 Matched Placebo or Zolpidem Matched Placebo

Intervention Type: DRUG

E2006-matched placebo capsules or zolpidem-matched placebo tablets.

Part A: E2006 Matched Placebo

Group Type: EXPERIMENTAL

E2006 Matched Placebo

Intervention Type: DRUG

E2006-matched placebo capsule.

Part B: E2006 2.5 mg

Group Type: EXPERIMENTAL

E2006 2.5 mg

Intervention Type: DRUG

E2006 2.5 mg capsule.

Part B: E2006 10 mg

Group Type: EXPERIMENTAL

E2006 10.0 mg

Intervention Type: DRUG

E2006 10.0 mg capsule.

Part B: E2006 25 mg

Group Type: EXPERIMENTAL

E2006 25.0 mg

Intervention Type: DRUG

E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each).

Interventions

E2006 1.0 mg

E2006 1.0 mg capsule.

Intervention Type: DRUG

E2006 2.5 mg

E2006 2.5 mg capsule.

Intervention Type: DRUG

E2006 5.0 mg

E2006 5.0 mg (2 capsules of 2.5 mg each).

Intervention Type: DRUG

E2006 10.0 mg

E2006 10.0 mg capsule.

Intervention Type: DRUG

E2006 25.0 mg

E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each).

Intervention Type: DRUG

E2006 50.0 mg

E2006 50.0 mg capsule.

Intervention Type: DRUG

E2006 100 mg

E2006 100 mg (2 capsules of 50 mg each).

Intervention Type: DRUG

E2006 200 mg

E2006 200 mg (4 capsules of 50 mg each).

Intervention Type: DRUG

Zolpidem 10 mg

Zolpidem 10 mg immediate release tablet.

Intervention Type: DRUG

E2006 Matched Placebo or Zolpidem Matched Placebo

E2006-matched placebo capsules or zolpidem-matched placebo tablets.

Intervention Type: DRUG

E2006 Matched Placebo

E2006-matched placebo capsule.

Intervention Type: DRUG

Other Intervention Names

Lemborexant; Lemborexant; Lemborexant; Lemborexant; Lemborexant; Lemborexant; Lemborexant; Lemborexant

Eligibility Criteria

Inclusion Criteria

Healthy Subjects:

• With habitual time in bed > 7 hours, with lights out 2200 to 2400 and lights on 0600 to 0800
• Who report typical sleep latency of </= 30 minutes
• With typical total sleep time (TST) >/= 420 minutes

Primary Insomnia Subjects:

• Otherwise healthy adult male and female subjects with a diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision [DSM-IV-TR]) present at the time of Screening for at least 3 months
• With a score of > 15 on the Insomnia Severity Index (ISI) at Screening
• Who report taking >/= 30 minutes to fall asleep on at least 3 nights per week for the past month
• Who report 6.5 hours sleep or less on at least 3 nights per week for the past month
• With mean latency to persistent sleep (LPS) on both baseline nights of >/= 20 minutes with neither night < 15 minutes
• With mean wake after sleep onset (WASO) >/= 20 minutes on both baseline nights, with neither night < 15 minutes or mean TST > 420 minutes

Exclusion Criteria

• With a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg syndrome [RLS], narcolepsy, or circadian rhythm disorder) other than primary insomnia (for Part B)
• Subjects with any clinically abnormal symptom or organ impairment found in medical history, symptoms/signs, vital signs, ECG finding, or laboratory test results which require medical treatment
• All females must be of non-childbearing potential
• With a known history of significant neurological or serious psychiatric illness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinilabs, Inc.

New York, New York, United States

Community Research

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

E2006-A001-001

Identifier Type: -

Identifier Source: org_study_id