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

Taisho Pharmaceutical Co., LTD.0 个研究点目标入组 24 人开始时间: 2022年12月26日最近更新: 2025年2月27日

适应症

试验速览

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•<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 subjects 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.

•<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 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.

Plasma concentration of unchanged form and its metabolites

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