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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-23

Study Completion Date

2026-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Patients With Mild or Moderate Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mild hepatic impairment

Group Type EXPERIMENTAL

TS-172

Intervention Type DRUG

Single oral administration of TS-172 20mg

Moderate hepatic impairment

Group Type EXPERIMENTAL

TS-172

Intervention Type DRUG

Single oral administration of TS-172 20mg

Normal hepatic function

Group Type EXPERIMENTAL

TS-172

Intervention Type DRUG

Single oral administration of TS-172 20mg

Interventions

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TS-172

Single oral administration of TS-172 20mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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

Exclusion Criteria

1. Patients with medical history of liver resection or liver transplantation
2. Patients with grade II or higher hepatic encephalopathy

1. Subjects with current condition or medical history of diseases that are ineligible for participation in the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No