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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01294540
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : August 29, 2013
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Drug: E2609 Drug: Placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2010
Primary Completion Date : October 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental: 1 Drug: Drug: E2609
E2609 orally at varying ascending doses
Placebo Comparator: Placebo Comparator: 2 Drug: Placebo
Matching Placebo



Primary Outcome Measures :
  1. Safety and tolerability as evidenced by the number of subjects with adverse events [ Time Frame: 38 days ]

Secondary Outcome Measures :
  1. To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses [ Time Frame: 4 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01294540     History of Changes
Other Study ID Numbers: E2609-A001-001
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders