Status:
COMPLETED
A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects
Lead Sponsor:
Eisai Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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) followi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01221259
Start Date
January 1 2010
End Date
November 1 2012
Last Update
May 22 2013
Active Locations (1)
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1
Overland Park, Kansas, United States