NCT07231029招募中1 期
An Open-label Pharmacokinetic Study of TS-172 in Patients With Hepatic Impairment
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Plasma concentrations of unchanged form and metabolites
研究概览
简要总结
An open-label study to evaluate the effect of TS-172 administration on pharmacokinetics in patients with hepatic impairment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<Inclusion criteria for patients with hepatic impairment>
- •Japanese male and female patients whose age is >=18 and <=75 years at the time of obtaining informed consent
- •Patients with chronic hepatic impairment
- •Patients who were classified by the principal investigator or sub-investigator as Class A (mild) or Class B (moderate) by Child-Pugh classification at the screening test Other protocol defined inclusion criteria could apply.
- •<Inclusion criteria for subjects with normal hepatic function>
- •Japanese male and female patients whose age is >=18 and <=75 years at the time of obtaining informed consent
- •Subjects whose body mass index is >=18.5 and <35.0 at the screening test Other protocol defined inclusion criteria could apply.
排除标准
- •for patients with hepatic impairment>
- •Patients with medical history of liver resection or liver transplantation
- •Patients with grade II or higher hepatic encephalopathy
- •Patients whose eGFR is <45 mL/min/1.73 m2 at screening test Other protocol defined exclusion criteria could apply.
- •<Exclusion criteria for subjects with normal hepatic function>
- •Subjects with current condition or medical history of diseases that are ineligible for participation in the study
- •Subjects whose eGFR is <60 mL/min/1.73 m2 at screening test Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
Mild hepatic impairment
Experimental
干预措施: TS-172 (Drug)
Moderate hepatic impairment
Experimental
干预措施: TS-172 (Drug)
Normal hepatic function
Experimental
干预措施: TS-172 (Drug)
结局指标
主要结局
Plasma concentrations of unchanged form and metabolites
时间窗: Up to 48 hours after dosing
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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