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

RecruitingPhase 1Ages 18 Years - 75 YearsAllTaisho Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
\<Inclusion criteria for patients with hepatic impairment\> 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. \<Inclusion criteria for subjects with normal hepatic function\> 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. \<Exclusion criteria for patients with hepatic impairment\> 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. \<Exclusion criteria for subjects with normal hepatic function\> 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.
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What it tests

  • TS-172
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Where

1 site
Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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