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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Inc.

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