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
About this trial
This is an interventional treatment trial for Alzheimer's Disease
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
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
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
We'll reach out to this number within 24 hrs