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

CNS Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673451
• Other study ID #: E2006-A001-002
• Status: Completed
• Phase: Phase 1
• First received: August 21, 2012
• Last updated: October 10, 2013
• Start date: August 2012
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• CNS

Intervention

Drug:
• E2006
Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules
• 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

Locations

Country	Name	City	State
United States	Parexel, California Clinical Trials	Culver City	California

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse events (AEs)		28 days	Yes
Secondary	Plasma concentrations of E2006		Part A up to 288 hours postdose; Part B: up to 324 hours postdose	No