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NCT Number: NCT07231029

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location status: Recruiting

Location contact

Taisho Director Taisho Director

CONTACT

[email protected]

81-3-3985-1118

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

<Inclusion criteria for patients with hepatic impairment>

  • Japanese male and female patients whose age is >=18 and <=75 years at the time of obtaining informed consent
  • Patients with chronic hepatic impairment
  • 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>

  • Japanese male and female patients whose age is >=18 and <=75 years at the time of obtaining informed consent
  • 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>

  • Patients with medical history of liver resection or liver transplantation
  • Patients with grade II or higher hepatic encephalopathy
  • 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>

  • Subjects with current condition or medical history of diseases that are ineligible for participation in the study
  • Subjects whose eGFR is <60 mL/min/1.73 m2 at screening test Other protocol defined exclusion criteria could apply.

Treatment and study plan

TS-172

Drug

Single oral administration of TS-172 20mg

Primary outcomes

  1. Plasma concentrations of unchanged form and metabolites

    Time frame: Up to 48 hours after dosing

Study contacts

Contact information is provided by the study sponsor or research team.

Taisho Pharmaceutical Co., Ltd.

CONTACT

[email protected]

81-3-3985-1118

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label Pharmacokinetic Study of TS-172 in Patients With Hepatic Impairment

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 17, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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