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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
  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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, 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:


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 ]

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 19, 2017