NIPH Clinical Trials Search

A pharmacokinetic study of TS-172 in patients with hepatic impairment

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Hyperphosphatemia
Date of first enrollment	23/12/2025
Target sample size	24
Countries of recruitment
Study type	Interventional
Intervention(s)	Single oral administration of TS-172 20mg during fasting

Outcome(s)

Primary Outcome	Plasma concentrations of unchanged form and metabolites
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 75age old
Gender	Both
Include criteria	<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.
Exclude criteria	<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.