Skip to main content
OpenTrials
Completed

NCT Number: NCT01294540

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drug: E2609

Drug

E2609 orally at varying ascending doses

Placebo

Drug

Matching Placebo

Primary outcomes

  1. Safety and tolerability as evidenced by the number of subjects with adverse events

    Time frame: 38 days

Secondary outcomes

  1. To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 11, 2011
Registry last updated
Aug 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.