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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Drug: E2609
Placebo
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Glendale Adventist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: 1

Placebo Comparator: 2

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability as evidenced by the number of subjects with adverse events

Secondary Outcome Measures

To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses

Full Information

First Posted
February 10, 2011
Last Updated
August 28, 2013
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01294540
Brief Title
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: 1
Arm Type
Experimental
Arm Title
Placebo Comparator: 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Drug: E2609
Intervention Description
E2609 orally at varying ascending doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Safety and tolerability as evidenced by the number of subjects with adverse events
Time Frame
38 days
Secondary Outcome Measure Information:
Title
To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Yen
Organizational Affiliation
Glendale Adventist Medical Center, Glendale, California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glendale Adventist Medical Center
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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