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

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: E2212; Drug: placebo

• Registration Number: NCT01221259
• Lead Sponsor: Eisai Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Primary Completion: 2011-10
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-05-20
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drug E2212	E2212	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of single ascending oral doses of E2212 in healthy subjects.	21 days