Status:
COMPLETED
A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006
Lead Sponsor:
Eisai Inc.
Conditions:
Insomnia
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
October 5 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2012
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01463098
Start Date
October 5 2011
End Date
August 11 2012
Last Update
January 18 2020
Active Locations (2)
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1
Clinilabs, Inc.
New York, New York, United States, 10019
2
Community Research
Cincinnati, Ohio, United States