jRCT2031240405招募中不适用
A phase 1 study to evaluate the relative bioavailability of and food effect on pharmacokinetics of S-337395 tablets in Japanese healthy adults, and the safety of multiple doses of S-337395 in Japanese healthy elderly participants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 主要终点
- Laboratory tests
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Part 1,3,4,5 (Group1) :
- •Those who aged >=18 to =<55 years, at the time of signing the ICF.
- •Those who have BMI of >=18.5 to =<30.0
- •Part 2,5 (Group2) :
- •Those who aged >= 65 years, at the time of signing the ICF
- •Those who have BMI of >=18.5 to =< 30.0, and body weight of >= 40 kg
排除标准
- •Considered by the investigator or subinvestigator (suitably qualified) to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, cardiovascular, gastrointestinal or neurological disorders that are considered by the investigator to constitute a safety risk upon the study drug administration or to interfere with the interpretation of data.
结局指标
主要结局
Laboratory tests
时间窗: Part 2,5
hematology, blood chemistry, and urinalysis
Vital signs
时间窗: Part 2,5
systolic and diastolic blood pressure, pulse rate, respiratory rate, and temperature
次要结局
未报告次要终点
研究者
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