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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01294540

Enrollment

Registered

2011-02-11

Start date

2010-12-31

Completion date

2011-12-31

Last updated

2013-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

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.

Interventions

DRUGDrug: E2609

E2609 orally at varying ascending doses

DRUGPlacebo

Matching Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability as evidenced by the number of subjects with adverse events	38 days

Secondary

Measure	Time frame
To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses	4 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026