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

Eisai

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: Placebo

Drug: E2609

Study type

Interventional

Funder types

Industry

Identifiers

NCT03055962

E2609-J081-014

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

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