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Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01294540
First received: February 10, 2011
Last updated: June 4, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a single dose of 50 mg in healthy elderly volunteers.


Condition Intervention Phase
Alzheimer's Disease
 Drug: Drug: E2609
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Doses of E2609 in Healthy Subjects and an Elderly Cohort

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Safety and tolerability as evidenced by the number of subjects with adverse events [ Time Frame: 38 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: December 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental: 1 Drug: Drug: E2609
E2609 orally at varying ascending doses
Placebo Comparator: Placebo Comparator: 2 Drug: Placebo
Matching Placebo

Detailed Description:

The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, at doses up to 100 mg or the maximum dose that can be tolerated, (2) a single dose of 25 mg or lower in healthy elderly volunteers.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • Healthy males and females
  • Aged 30 to 55 years, inclusive (Cohorts 1 through 5); aged 65 to 85 years, inclusive (Cohort 6)
  • Body mass index (BMI) of 18 to 32kg/m^2 at Screening
  • Additional inclusion criteria for Cohort 6 (healthy elderly subjects)

Exclusion

  • Females of child-bearing potential
  • Personal or family history of neurological abnormalities
  • Any clinical abnormality of the electrocardiogram (ECG)at Screening and check-in
  • A family history of cardiac abnormalities
  • Thyroid abnormalities
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294540

Locations
United States, California
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Mark Yen Glendale Adventist Medical Center, Glendale, California
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01294540     History of Changes
Other Study ID Numbers: E2609-A001-001
Study First Received: February 10, 2011
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2012