NCT05624944已完成1 期
An Open-label Pharmacokinetic Study of TS-142 in Patients with Hepatic Impairment
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Plasma concentration
研究概览
简要总结
This is an open-label pharmacokinetic study of TS-142 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
- 是
入选标准
- •<Inclusion criteria for patients with hepatic impairment>
- •Japanese male and female who are aged 18 to 75 years at the time of informed consent
- •Patients with cirrhosis or chronic hepatic impairment
- •Patients classified as Child-Pugh classification A (mild) or B (moderate) by the principal investigator or sub-investigator at the screening test Other protocol defined inclusion criteria could apply.
- •<Inclusion criteria for subject with normal hepatic function>
- •Japanese male and female who are aged 18 to 75 years at the time of informed consent
- •Body Mass Index (BMI) between 18.5 and 35.0 at the screening test Other protocol defined inclusion criteria could apply.
排除标准
- •<Exclusion criteria for patients with hepatic impairment>
- •Patients who have a history of liver resection or liver transplant
- •Patients with hepatic encephalopathy of grade II or higher
- •Patients with epidermal growth factor receptor (eGFR) less than 45 mL/min/1.73 m2 at the screening test Other protocol defined exclusion criteria could apply.
- •<Exclusion criteria for subjects with normal hepatic function>
- •Subjects who are judged to have any disease by the principal investigator or sub-investigator
- •Subjects with eGFR less than 60 mL/min/1.73 m2 at the screening test Other protocol defined exclusion criteria could apply.
研究组 & 干预措施
Normal hepatic function
Experimental
Subjects with normal hepatic function will receive a single-dose of 5 mg of TS-142
干预措施: TS-142 5 mg (Drug)
Mild hepatic impairment
Experimental
Patients with mild hepatic impairment will receive a single-dose of 5 mg of TS-142
干预措施: TS-142 5 mg (Drug)
Moderate hepatic impairment
Experimental
Patients with moderate hepatic impairment will receive a single-dose of 5 mg of TS-142
干预措施: TS-142 5 mg (Drug)
结局指标
主要结局
Plasma concentration
时间窗: Predose and up to 48 hours postdose
Plasma concentration of unchanged form and its metabolite
Pharmacokinetic parameters
时间窗: Predose and up to 48 hours postdose
Apparent total body clearance adjusted by unbound fraction of unchanged form (CL(unbound)/F)
次要结局
- Incidence of adverse events(From administration of investigational product through 10 days after administration of investigational product)
研究者
研究点 (1)
Loading locations...
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