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An open-label pharmacokinetic study of TS-172 in patients with hepatic impairment

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

Seiji Mita

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

shu_chiken@taisho.co.jp

Development Management Development Headquarters

Taisho Pharmaceutical Co., LTD.

TOSHIMA-KU,TOKYO 170-8633 JAPAN

+81-3-3985-1118

shu_chiken@taisho.co.jp

Recruiting

Nov. 01, 2025

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

<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.

Both

Hyperphosphatemia

Single oral administration of TS-172 20mg during fasting

Plasma concentrations of unchanged form and metabolites

+81-42-648-5551

Oct. 03, 2025

No

none