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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Eisai Inc.

Criteria

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