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

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

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).

Study Overview

• Status: Completed
• Conditions: CNS
• Intervention / Treatment: Drug: Placebo comparator; Drug: E2006

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Culver City, California, United States, 90232
      • Parexel, California Clinical Trials
    • Glendale, California, United States, 91206

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo comparator	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
Experimental: E2006	Drug: E2006; Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Investigators: Principal Investigator: Dohwa Kim, Parexel

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: August 23, 2012
• First Posted (Estimate): August 28, 2012

Study Record Updates

• Last Update Posted (Estimate): October 11, 2013
• Last Update Submitted That Met QC Criteria: October 10, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: insomnia
• Other Study ID Numbers: E2006-A001-002