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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01463098
First received: October 26, 2011
Last updated: May 20, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Insomnia
Drug: E2006 1.0 mg
Drug: E2006 2.5 mg
Drug: E2006 5.0 mg
Drug: E2006 10.0 mg
Drug: E2006 25.0 mg
Drug: E2006 50.0 mg
Drug: E2006 100 mg
Drug: E2006 200 mg
Drug: zolpidem 10 mg
Drug: zolpidem - matched placebo
Drug: E2006 - matched placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Safety and tolerability by monitoring the number of subjects with adverse events [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Part A: plasma concentrations of E2006 [ Time Frame: up to 72 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E2006 1.0 mg Drug: E2006 1.0 mg
1.0 mg, or placebo
Experimental: E2006 2.5 mg Drug: E2006 2.5 mg
2.5 mg or placebo
Experimental: E2006 5.0 mg Drug: E2006 5.0 mg
5.0 mg or placebo
Experimental: E2006 10.0 mg Drug: E2006 10.0 mg
10.0 mg or placebo
Experimental: E2006 25.0 mg Drug: E2006 25.0 mg
25.0 mg or placebo
Experimental: E2006 50.0 mg Drug: E2006 50.0 mg
50.0 mg or placebo
Experimental: E2006 100 mg Drug: E2006 100 mg
100mg or placebo
Experimental: E2006 200 mg Drug: E2006 200 mg
200 mg or placebo
Experimental: zolpidem 10 mg Drug: zolpidem 10 mg
10 mg
Experimental: zolpidem matched placebo
zolpidem - matched placebo (Part B Only)
Drug: zolpidem - matched placebo
Part B only
Experimental: E2006 - matched placebo
(Part A and Part B)
Drug: E2006 - matched placebo
(Part A and Part B)

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Key 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

Key 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463098

Locations
United States, New York
Clinilabs, Inc.
New York,, New York, United States, 10019
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Mardik Donikyan, MD Clinilabs, Inc. 423 West 55th Street, 4th Floor New York, NY 10019
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01463098     History of Changes
Other Study ID Numbers: E2006-A001-001
Study First Received: October 26, 2011
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014