NCT01294540

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 29, 2013

Status Verified

August 1, 2013

Enrollment Period

10 months

First QC Date

February 10, 2011

Last Update Submit

August 28, 2013

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

    38 days

Secondary Outcomes (1)

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

    4 days

Study Arms (2)

Experimental: 1

EXPERIMENTAL
Drug: Drug: E2609

Placebo Comparator: 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Drug: E2609DRUG

E2609 orally at varying ascending doses

Experimental: 1
PlaceboDRUG

Matching Placebo

Placebo Comparator: 2

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Mark Yen

    Glendale Adventist Medical Center, Glendale, California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

December 1, 2010

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

August 29, 2013

Record last verified: 2013-08

Locations

US(1)