jRCT2080225113招募中1 期
An Open-label Parallel-Group Study to Evaluate Pharmacokinetics of E7090 and its Metabolite in Subjects with Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 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
- 干预模型
- Open(masking not used), Parallel assignment
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 79age old under（—）
- 性别
- All
入选标准
- •BMI between 18 to 40 kg/m
- •For participants with hepatic Impairment: stable hepatic impairment conforming to Child-Pugh classification A and B.
- •For Healthy subjects: matched to participants with hepatic impairment with regard to age (+/-10 years), body weight (+/-20%), race and gender.
排除标准
- •[Hepatic impairment Cohort]
- •1.Any significant acute medical illness, such as new conditions or the exacerbation of pre-existing conditions, within 8 weeks of dosing.
- •2.Presence of severe ascites, edema, or uncontrolled hepatic encephalopathy.
- •3.The subject's standard therapy/concomitant medication for diseases related to hepatic impairment has not remained stable/unchanged for at least 2 weeks prior to dosing.
- •[Healthy subject Cohort]
- •1.Subjects tested positive for syphilis (qualitative).
- •2.Any abnormal finding based on physical examination, assessment of vital signs, and ECG, or laboratory test results that requires treatment or clinical follow-up based on the investigator's opinion.
结局指标
主要结局
-
pharmacokinetics, drug concentration, pharmacokinetic parameter
次要结局
未报告次要终点
研究者
研究点 (1)
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