Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese 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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-14

Study Completion Date

2017-04-11

Brief Summary

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Study E2609-J081-014 is a single-center, randomized, double-blind, placebo-controlled study conducted to evaluate the safety and tolerability of multiple oral doses of E2609 50 milligrams (mg), administered once daily for 14 days, in healthy Japanese participants aged 50 to 85 years.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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E2609 50 mg

Participants will receive E2609 50 milligrams (mg) orally once a day for 14 days.

Group Type EXPERIMENTAL

E2609

Intervention Type DRUG

tablet

Placebo

Participants will receive matching placebo orally once a day for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

tablet

Interventions

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E2609

tablet

Intervention Type DRUG

Placebo

tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males and females
* Aged 50 to 85 years, inclusive at time of consent
* Body mass index (BMI) of 17.6 to 32 kilograms per meters squared (kg/m\^2) at Screening

Exclusion Criteria

* Personal or family history of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (eg, history of head trauma or concussion, previous alcohol abuse, substance abuse)
* A history of cerebrovascular accident or non-vasovagal-related loss of consciousness
* Any clinically significant findings on neurological examination
* A family history of Long QT Syndrome or a presence of other risk factors for Torsades de Pointes (TDP), such as hypokalemia, hypomagnesemia, or hypocalcemia
* History of cardiac arrhythmias, ischemic heart disease, or cerebrovascular disease
* A history of gastrointestinal surgery that may affect the pharmacokinetic profile of E2609 (eg, hepatectomy, nephrotomy, digestive organ resection)
* A known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes