2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly Subjects

Study Overview
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Brief Summary
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This is a single-center, randomized, double-blind, placebo-controlled, sequential, multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy adults receiving evening dosing) and Part B (one cohort of elderly adults receiving evening dosing).

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of E2006 in Healthy Adult and Elderly Subjects

Conditions
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CNS

Intervention / Treatment
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* Drug: E2006
* Drug: Placebo comparator


Participation Criteria
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Eligibility Criteria
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Included: Healthy males or females, ages 18 to 55 years (Part A) or 65 to 80 years (Part B) Who report typical time in bed 7.5 to 9 hours Who report typical bedtime 22:00 - 24:00 and typical wake time 06:00 - 08:00 Who report typical sleep latency of <= 30 minutes All females must be of non-childbearing potential, or subjects who have been sterilized surgically or who are otherwise proven sterile. Females must have a negative serum beta-human chorionic gonadotropin (Beta-hCG) test result at Screening and a negative urine pregnancy test at Baseline. Body mass index BMI > 18 and 32 kg/m2 at Screening Excluded: Performed shift work within 2 weeks prior to Screening Had taken a flight across three or more time zones in the 7 days prior to Screening Female subjects who are nursing With a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profile of E2006 With a known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy Hypersensitivity to the study drug or any of the excipients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo comparator<br> | Drug: Placebo comparator<br>* E2006-matched placebo (Part A and Part B); Part B: dose level to be determined based on results of Part A, administered as capsules<br>|
| Experimental: E2006<br> | Drug: E2006<br>* Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse events (AEs) |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of E2006 |  | Part A up to 288 hours postdose; Part B: up to 324 hours postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia