JPRN-jRCT2080223723未知1 期
A Phase 1 Clinical Study of E6130 -Clinical Pharmacology Study in Healthy Adult Male Subjects
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 44
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
- >= 20age old 至 <= 44age old（—）
- 性别
- Male
入选标准
- •Main Inclusion Criteria
- •(1) Japanese or Caucasian healthy adult males aged >=20 and <45 years at the time of informed consent who are non-smokers or able to stop smoking from at least 4 weeks before study drug administration until the post-treatment examination.
- •(2) Has voluntarily consented, in writing, to participate in this study.
- •(3) Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.
排除标准
- •Main Exclusion Criteria
- •(1) History of surgical treatment may affect the pharmacokinetics of the study drug at screening.
- •(2) Suspected to have clinically abnormal symptoms or impairment of organ function requiring treatment on the basis of history and complications at screening, and physical findings, vital signs, ECG findings, or laboratory values at screening or baseline.
- •(3) History of drug allergy at screening.
- •(4) Judged by the investigator or subinvestigator to be inappropriate for participation in this study.
研究者
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