A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | October 2011 |
| Contact: | Eisai Medical Services |
| Phone: | 1-888-422-4743 |
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
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.
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
- 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
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