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A Pharmacokinetic Study of TS-172 in Patients With Hepatic Impairment

A Pharmacokinetic Study of TS-172 in Patients With Hepatic Impairment

Recruiting
18-75 years
All
Phase 1
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Overview

An open-label study to evaluate the effect of TS-172 administration on pharmacokinetics in patients with hepatic impairment

Eligibility

\ 1. Japanese male and female patients whose age is \>=18 and \<=75 years at the time of obtaining informed consent 2. Patients with chronic hepatic impairment 3. 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. \ 1. Japanese male and female patients whose age is \>=18 and \<=75 years at the time of obtaining informed consent 2. Subjects whose body mass index is \>=18.5 and \<35.0 at the screening test Other protocol defined inclusion criteria could apply. \ 1. Patients with medical history of liver resection or liver transplantation 2. Patients with grade II or higher hepatic encephalopathy 3. Patients whose eGFR is \<45 mL/min/1.73 m2 at screening test Other protocol defined exclusion criteria could apply. \ 1. Subjects with current condition or medical history of diseases that are ineligible for participation in the study 2. Subjects whose eGFR is \<60 mL/min/1.73 m2 at screening test Other protocol defined exclusion criteria could apply.

Study details
    Patients With Mild or Moderate Hepatic Impairment

NCT07231029

Taisho Pharmaceutical Co., Ltd.

1 February 2026

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