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

Eisai

Status and phase: Completed; Phase 1

Conditions: Insomnia

Treatments: Drug: E2006 100 mg; Drug: E2006 Matched Placebo or Zolpidem Matched Placebo; Drug: Zolpidem 10 mg; Drug: E2006 1.0 mg; Drug: E2006 200 mg; Drug: E2006 2.5 mg; Drug: E2006 Matched Placebo; Drug: E2006 25.0 mg; Drug: E2006 50.0 mg; Drug: E2006 10.0 mg; Drug: E2006 5.0 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01463098

E2006-A001-001

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

122 participants in 14 patient groups

Part A: E2006 1.0 mg

Experimental group

Treatment:

Drug: E2006 1.0 mg

Part A: E2006 2.5 mg

Experimental group

Treatment:

Drug: E2006 2.5 mg

Part A: E2006 5.0 mg

Experimental group

Treatment:

Drug: E2006 5.0 mg

Part A: E2006 10.0 mg

Experimental group

Treatment:

Drug: E2006 10.0 mg

Part A: E2006 25.0 mg

Experimental group

Treatment:

Drug: E2006 25.0 mg

Part A: E2006 50.0 mg

Experimental group

Treatment:

Drug: E2006 50.0 mg

Part A: E2006 100 mg

Experimental group

Treatment:

Drug: E2006 100 mg

Part A: E2006 200 mg

Experimental group

Treatment:

Drug: E2006 200 mg

Part B: Zolpidem 10 mg

Experimental group

Treatment:

Drug: Zolpidem 10 mg

Part B: E2006 Matched Placebo or Zolpidem Matched Placebo

Experimental group

Treatment:

Drug: E2006 Matched Placebo or Zolpidem Matched Placebo

Part A: E2006 Matched Placebo

Experimental group

Treatment:

Drug: E2006 Matched Placebo

Part B: E2006 2.5 mg

Experimental group

Treatment:

Drug: E2006 2.5 mg

Part B: E2006 10 mg

Experimental group

Treatment:

Drug: E2006 10.0 mg

Part B: E2006 25 mg

Experimental group

Treatment:

Drug: E2006 25.0 mg