NCT01294540

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Drug: E2609	E2609 orally at varying ascending doses
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2011-02-11
• Last updated: 2013-08-29

Locations

1 site across 1 country: United States