A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
- Conditions
- Healthy Japanese Subject
- Registration Number
- JPRN-jRCT2080223449
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 16
(1)Healthy males and females
(2)Aged 50 to 85 years, inclusive at time of consent
(3)Body mass index (BMI) of 17.6 to 32 kilograms per meters squared (kg/m2) at Screening
(1)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)
(2)A history of cerebrovascular accident or non-vasovagal-related loss of consciousness
(3)Any clinically significant findings on neurological examination
(4)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
(5)A history of cardiac arrhythmias, ischemic heart disease, or cerebrovascular disease
(6)A history of gastrointestinal surgery that may affect the pharmacokinetic profile of E2609 (eg, hepatectomy, nephrotomy,
digestive organ resection)
(7)A known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method