Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-11-30

Brief Summary

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The purpose of this single-center, randomized, double-blind, placebo-controlled, study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered to healthy elderly subjects.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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E2609

E2609 at ascending doses

Group Type EXPERIMENTAL

E2609

Intervention Type DRUG

E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.

Interventions

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E2609

E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.

Intervention Type DRUG

Placebo

E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males and females
* Female subjects must be of non-childbearing potential
* Aged 50 to 85 years, inclusive BMI of 18 to 32 kg/m2 at screening
* Thyroid function tests within normal rangeMini-Mental State Examination score of 28-30, inclusive

Exclusion Criteria

* History of neurological abnormalities, including seizures
* Any clinically significant abnormality of the ECG at Screening and Baseline including QTc prolongation
* History of ischemic heart disease, cardiac arrhythmias, cerebrovascular diseases
* Other medical conditions that are not stably controlled
* Presence of orthostatic hypotension

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes