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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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Drug: E2212
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: January 2010
Study Completion Date: November 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug E2212 Drug: E2212
single ascending doses ranging from 10mg to 250mg
Placebo Comparator: Placebo Drug: placebo
a single dose of matching placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221259

Locations
United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Philip Lee, Md Quintiles Phase One Service
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01221259     History of Changes
Other Study ID Numbers: E2212-A001-001
Study First Received: October 13, 2010
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013