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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221259
• Other study ID #: E2212-A001-001
• Status: Completed
• Phase: Phase 1
• First received: October 13, 2010
• Last updated: May 20, 2013
• Start date: January 2010
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• E2212
single ascending doses ranging from 10mg to 250mg
• placebo
a single dose of matching placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of single ascending oral doses of E2212 in healthy subjects.		21 days	Yes