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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01673451
First received: August 21, 2012
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
CNS
Drug: E2006
Drug: Placebo comparator
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Incidence of Adverse events (AEs) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentrations of E2006 [ Time Frame: Part A up to 288 hours postdose; Part B: up to 324 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: August 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673451

Locations
United States, California
Parexel, California Clinical Trials
Culver City, California, United States, 90232
Glendale, California, United States, 91206
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Dohwa Kim Parexel
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01673451     History of Changes
Other Study ID Numbers: E2006-A001-002
Study First Received: August 21, 2012
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
insomnia

ClinicalTrials.gov processed this record on August 21, 2014