JPRN-jRCT2080223305未知1 期
A Phase 1 Single Dose Study of E6130 in Japanese Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 68
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
- •(1) Japanese 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
- •(1) History of surgical treatment that 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
相似试验
未知
1 期
A phase 1, single-dose study of E6011 in Japanese healthy adult subjectsJPRN-jRCT2080221973Eisai Co., Ltd.64
已完成
1 期
A Single Dose Study of E6130 in Japanese Healthy Adult Male SubjectsJapanese Healthy Adult Male ParticipantsNCT02902978EA Pharma Co., Ltd.56
终止
2 期
A Clinical Phase 2 Study of E6011 in Japanese Subjects with Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic AcidPrimary Biliary CholangitisJPRN-jRCT2080223460EA Pharma Co.,Ltd.80
已完成
1 期
A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects (Study E6011-J081-001)Healthy Male VolunteersNCT01731275Eisai Co., Ltd.64
未知
1 期
A phase 1/2 study of E6005 in Japanese patients with atopic dermatitisAtopic dermatitsJPRN-jRCT2080221229Eisai Co., Ltd.40
