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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01221259

Run by

Eisai Inc.

People needed

60

Starts

2010-01-01

Expected to finish

2012-11-01

Last updated by the study team

2013-05-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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