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

An Open-label 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

Study Overview

• Status: Recruiting
• Conditions: Patients With Mild or Moderate Hepatic Impairment
• Intervention / Treatment: Drug: TS-172

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Taisho Pharmaceutical Co., Ltd.; Phone Number: 81-3-3985-1118; Email: shu_chiken@taisho.co.jp

Study Locations

• Japan
  • Tokyo, Japan
    • Recruiting
    • Taisho Pharmaceutical Co., Ltd selected site
    • Contact: Taisho Director Taisho Director; Phone Number: 81-3-3985-1118; Email: shu_chiken@taisho.co.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

<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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal hepatic function	Drug: TS-172; Single oral administration of TS-172 20mg
Experimental: Mild hepatic impairment	Drug: TS-172; Single oral administration of TS-172 20mg
Experimental: Moderate hepatic impairment	Drug: TS-172; Single oral administration of TS-172 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations of unchanged form and metabolites	Up to 48 hours after dosing

Collaborators and Investigators

• Sponsor: Taisho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taisho Director Taisho Director, Taisho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2025
• Primary Completion (Estimated): October 26, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TS172-03-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No