JPRN-jRCT2080223449未知1 期
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
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •(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
排除标准
- •(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
研究者
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