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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Overland Park, Kansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E2212

Drug

single ascending doses ranging from 10mg to 250mg

Placebo

Drug

a single dose of matching placebo

Primary outcomes

To evaluate the safety and tolerability of single ascending oral doses of E2212 in healthy subjects.

Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2012
First posted: Oct 14, 2010
Registry last updated: May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed