NCT07231029

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
5mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Dec 2025Oct 2026

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 23, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2026

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

November 13, 2025

Last Update Submit

January 7, 2026

Conditions

Patients With Mild or Moderate Hepatic Impairment

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of unchanged form and metabolites

    Up to 48 hours after dosing

Study Arms (3)

Mild hepatic impairment

EXPERIMENTAL
Drug: TS-172

Moderate hepatic impairment

EXPERIMENTAL
Drug: TS-172

Normal hepatic function

EXPERIMENTAL
Drug: TS-172

Interventions

TS-172DRUG

Single oral administration of TS-172 20mg

Mild hepatic impairmentModerate hepatic impairmentNormal hepatic function

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with medical history of liver resection or liver transplantation
  • Patients with grade II or higher hepatic encephalopathy
  • Subjects with current condition or medical history of diseases that are ineligible for participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

RECRUITING

Study Officials

  • Taisho Director Taisho Director

    Taisho Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Central Study Contacts

Taisho Pharmaceutical Co., Ltd.

CONTACT

81-3-3985-1118shu_chiken@taisho.co.jp

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

December 23, 2025

Primary Completion (Estimated)

October 26, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)