Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort

Alzheimer's Disease Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Doses of E2609 in Healthy Subjects and an Elderly Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294540
• Other study ID #: E2609-A001-001
• Status: Completed
• Phase: Phase 1
• First received: February 10, 2011
• Last updated: August 28, 2013
• Start date: December 2010
• Est. completion date: December 2011

Study information

• Verified date: August 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

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a single dose of 50 mg in healthy elderly volunteers.

Description:

The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, at doses up to 100 mg or the maximum dose that can be tolerated, (2) a single dose of 25 mg or lower in healthy elderly volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

Inclusion:

• Healthy males and females

• Aged 30 to 55 years, inclusive (Cohorts 1 through 5); aged 65 to 85 years, inclusive (Cohort 6)

• Body mass index (BMI) of 18 to 32kg/m^2 at Screening

• Additional inclusion criteria for Cohort 6 (healthy elderly subjects)

Exclusion

• Females of child-bearing potential

• Personal or family history of neurological abnormalities

• Any clinical abnormality of the electrocardiogram (ECG)at Screening and check-in

• A family history of cardiac abnormalities

• Thyroid abnormalities

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Drug: E2609
E2609 orally at varying ascending doses
• Placebo
Matching Placebo

Locations

Country	Name	City	State
United States	Glendale Adventist Medical Center	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability as evidenced by the number of subjects with adverse events		38 days	Yes
Secondary	To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses		4 days	No