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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: August 28, 2013
Last verified: August 2013

February 10, 2011
August 28, 2013
December 2010
October 2011   (final data collection date for primary outcome measure)
Safety and tolerability as evidenced by the number of subjects with adverse events [ Time Frame: 38 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01294540 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Drug: E2609
    E2609 orally at varying ascending doses
  • Drug: Placebo
    Matching Placebo
  • Experimental: Experimental: 1
    Intervention: Drug: Drug: E2609
  • Placebo Comparator: Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
December 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
30 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01294540
E2609-A001-001
No
Eisai Inc.
Eisai Inc.
Not Provided
Principal Investigator: Mark Yen Glendale Adventist Medical Center, Glendale, California
Eisai Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP