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

• Sponsor: Eisai Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01673451
• Collaborator: (none)
• Enrollment: 24
• Locations: 2
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 12
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
CNS	Drug: E2006; Drug: Placebo comparator	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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 Start Date: Aug 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse events (AEs) [28 days]

Secondary Outcome Measures

1. Plasma concentrations of E2006 [Part A up to 288 hours postdose; Part B: up to 324 hours postdose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parexel, California Clinical Trials	Culver City	California	United States	90232
2		Glendale	California	United States	91206

Sponsors and Collaborators

• Eisai Inc.

Investigators

• Principal Investigator: Dohwa Kim, Parexel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eisai Inc.
• ClinicalTrials.gov Identifier: NCT01673451
• Other Study ID Numbers: E2006-A001-002
• First Posted: Aug 28, 2012
• Last Update Posted: Oct 11, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Eisai Inc.: insomnia

Study Results

No Results Posted as of Oct 11, 2013