CNS
Conditions
Keywords
insomnia
Brief summary
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).
Interventions
Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules
E2006-matched placebo (Part A and Part B); Part B: dose level to be determined based on results of Part A, administered as capsules
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse events (AEs) | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of E2006 | Part A up to 288 hours postdose; Part B: up to 324 hours postdose |
Countries
United States