jRCT2031210202已完成不适用
A Phase 1 study of S-217622 in healthy adult participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 主要终点
- -
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
- 20age old over 至 55age old under（—）
- 性别
- All
入选标准
- •Japanese healthy adult male participants (SAD Part, DDI with dexamethasone and prednisolone Part)
- •Japanese healthy adult male, white healthy adult male or Japanese healthy adult female participants (MAD Part)
- •Japanese healthy adult male and female participants (FE Part, DDI with midazolam Part)
- •White healthy adult male and female participants (W-MAD Part)
- •Participants must be 20 to 55 years of age inclusive, at the time of signing the informed consent form (SAD Part, MAD Part, DDI Part, FE Part, W-MAD Part)
- •Participants must be 65 years of age or older inclusive, at the time of signing the informed consent form (Elderly Part)
排除标准
- •History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data
- •Positive SARS-CoV-2 RT-PCR test at admission
结局指标
主要结局
-
Adverse events, physical examination, laboratory tests, vital signs, 12-lead ECG, holter ECG Pharmacokinetics (SAD Part, MAD Part, W-MAD Part, Elderly Part) Dexamethasone, prednisolone, and midazolam: Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z, lambdaz, MRT, CL/F, Vz/F (DDI Part) S-217622: Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z, lambdaz, MRT, CL/F, Vz/F (FE Part)
次要结局
未报告次要终点
研究者
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