An open-label pharmacokinetic study of TS-142 in patients with hepatic impairment

Mita Seiji0 个研究点目标入组 24 人开始时间: 2022年11月25日最近更新: 2024年4月1日

适应症

试验速览

暂无简介。

•1. Japanese male and female who are aged 18 to 75 years at the time of informed consent
•2. Patients with cirrhosis or chronic hepatic impairment
•3. 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.
•1. Japanese male and female who are aged 18 to 75 years at the time of informed consent
•2. Body Mass Index (BMI) between 18.5 and 35.0 at the screening test
•Other protocol defined inclusion criteria could apply.

•1. Patients who have a history of liver resection or liver transplant
•2. Patients with hepatic encephalopathy of grade II or higher
•3. Patients with eGFR less than 45 mL/min/1.73 m2 at the screening test
•Other protocol defined exclusion criteria could apply.
•1. Subjects who are judged to have any disease by the principal investigator or sub-investigator
•2. Subjects with eGFR less than 60 mL/min/1.73 m2 at the screening test
•Other protocol defined exclusion criteria could apply.

发起方

Mita Seiji