drugset / Trial / NCT01294540

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

NCT01294540

Phase 1 Completed 73 enrolled Eisai Inc.
RandomizedSingle-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-12
Primary completion
2011-10
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Elenbecestat Small molecule 25 mg Oral
Subject Elenbecestat Small molecule 50 mg Oral
Subject Elenbecestat Small molecule 100 mg Oral
Subject Elenbecestat Small molecule 800 mg Oral

Indications