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

NCT ID: NCT01221259

Last Updated: 2013-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Drug E2212

Group Type EXPERIMENTAL

E2212

Intervention Type DRUG

single ascending doses ranging from 10mg to 250mg

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

a single dose of matching placebo

Interventions

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E2212

single ascending doses ranging from 10mg to 250mg

Intervention Type DRUG

placebo

a single dose of matching placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Lee, Md

Role: PRINCIPAL_INVESTIGATOR

Quintiles Phase One Service

Locations

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Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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E2212-A001-001

Identifier Type: -

Identifier Source: org_study_id

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