Back to resultsA Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
E2212
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Healthy men and women of non-child bearing potential age 18 and 55 years old at the time of Screening;
- Body mass index (BMI) 18 and 30 kg/m2 at Screening;
- Are willing and able to comply with all aspects of the protocol; and
- Provide written informed consent.
Exclusion Criteria:
- Clinically important abnormalities on physical examination, vital signs or clinical laboratories.
- History of serious medical illness
- Smoking or use of tobacco-containing products within past 3 months
- History of alcohol or drug abuse within past 2 years
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Drug E2212
Placebo
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the safety and tolerability of single ascending oral doses of E2212 in healthy subjects.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01221259
Brief Title
A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects
Official Title
A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
November 2012 (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
This study is designed as a single ascending dose study in healthy subjects to evaluate safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) in plasma and Cerebrospinal (CSF) following single oral doses of E2212.
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug E2212
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
E2212
Intervention Description
single ascending doses ranging from 10mg to 250mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
a single dose of matching placebo
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of single ascending oral doses of E2212 in healthy subjects.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy men and women of non-child bearing potential age 18 and 55 years old at the time of Screening;
Body mass index (BMI) 18 and 30 kg/m2 at Screening;
Are willing and able to comply with all aspects of the protocol; and
Provide written informed consent.
Exclusion Criteria:
Clinically important abnormalities on physical examination, vital signs or clinical laboratories.
History of serious medical illness
Smoking or use of tobacco-containing products within past 3 months
History of alcohol or drug abuse within past 2 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Lee, Md
Organizational Affiliation
Quintiles Phase One Service
Official's Role
Principal Investigator
Facility Information:
City
Overland Park
State/Province
Kansas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects
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