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

Eisai Inc.0 sites60 target enrollmentJanuary 2010

ConditionsAlzheimer's Disease

InterventionsE2212 placebo

DrugsE2212 placebo

Overview

Phase: Phase 1
Intervention: E2212
Conditions: Alzheimer's Disease
Sponsor: Eisai Inc.
Enrollment: 60
Primary Endpoint: To evaluate the safety and tolerability of single ascending oral doses of E2212 in healthy subjects.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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) following single oral doses of E2212.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

November 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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