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A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01221259
First received: October 13, 2010
Last updated: May 20, 2013
Last verified: February 2013
History of Changes

October 13, 2010
May 20, 2013
January 2010
October 2011   (final data collection date for primary outcome measure)
To evaluate the safety and tolerability of single ascending oral doses of E2212 in healthy subjects. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01221259 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects
A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: E2212
    single ascending doses ranging from 10mg to 250mg
  • Drug: placebo
    a single dose of matching placebo
  • Experimental: Drug E2212
    Intervention: Drug: E2212
  • Placebo Comparator: Placebo
    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
60
November 2012
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy men and women of non-child bearing potential age 18 and 55 years old at the time of Screening;
  2. Body mass index (BMI) 18 and 30 kg/m2 at Screening;
  3. Are willing and able to comply with all aspects of the protocol; and
  4. Provide written informed consent.

Exclusion Criteria:

  1. Clinically important abnormalities on physical examination, vital signs or clinical laboratories.
  2. History of serious medical illness
  3. Smoking or use of tobacco-containing products within past 3 months
  4. History of alcohol or drug abuse within past 2 years
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01221259
E2212-A001-001
No
Eisai Inc.
Eisai Inc.
Not Provided
Principal Investigator: Philip Lee, Md Quintiles Phase One Service
Eisai Inc.
February 2013

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