2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly Subjects
Overview
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).
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: May 2013
Interventions
- Drug: E2006
- Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules
- Drug: Placebo comparator
- E2006-matched placebo (Part A and Part B); Part B: dose level to be determined based on results of Part A, administered as capsules
Arms, Groups and Cohorts
- Placebo Comparator: Placebo comparator
- Experimental: E2006
Clinical Trial Outcome Measures
Primary Measures
- Incidence of Adverse events (AEs)
- Time Frame: 28 days
Secondary Measures
- Plasma concentrations of E2006
- Time Frame: Part A up to 288 hours postdose; Part B: up to 324 hours postdose
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Eisai Inc.
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Dohwa Kim, Principal Investigator, Parexel
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