JPRN-jRCT2071200073已完成1 期
ONO-2909-01:ONO-2909 Phase I study Single and multiple oral dose study in healthy adult male subjects, elderly male and female subjects, and patients with narcolepsy
Osawa Masahiro0 个研究点目标入组 102 人开始时间: 2020年12月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
研究概览
简要总结
ONO-2909 was safe and well tolerated in healthy volunteers and patients with narcolepsy. Both Cmax and AUCinf generally increased in a dose-proportional manner and reached a steady state by Day 3 of repeated administration.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •1) Japanese healthy adult male subjects,Japanese elderly male or female subjects,Caucasian healthy adult male subjects
- •2) Age at the time of informed consent:18 to 45(Healthy adults),65 to 74(Elderly males/Elderly females)
- •3) BMI(at screening): 18.5 kg/m2 to less than 25.0 kg/m2/30.0 kg/m2(Japanese/Caucasian)
- •1) Age at the time of informed consent:18 to 74
- •2) Body weight(at screening)>=40 kg
- •3) Diagnosis of narcolepsy based on the International Classification of Sleep Disorders,3rd edition(The International Classification of Sleep Disorders_3 rd edition,ICSD_3)(Type 1 or Type 2).For NT1,the subject has the HLAD_QB1 *06:02 gene.
- •4) Epworth Sleepiness Scale score:>=11
排除标准
- •1) Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
- •2) Subjects with current or with a history of severe allergy to drugs or foods
- •3) Subjects with current or with a history of drug or alcohol abuse
- •1) Sleep disorders other than narcolepsy (Sleep apnea or Periodic limb movement disorder, etc)
- •2) Sleep_wake rhythm disorder due to external factors such as night work or irregular working hours
研究者
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