NCT07231029

RecruitingPhase 1

A Pharmacokinetic Study of TS-172 in Patients With Hepatic I...

Taisho Pharmaceutical Co., Ltd.Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

TS172-03-10

Study Type

interventional

Estimated enrollment

24

Locations

1 country

Sites

1

Timeline

Study Start

December 23, 2025

Actual (reported)

Primary Completion

October 26, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

October 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 24 participants
Study completion date: October 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 13, 2025
Actual (reported)
First Posted
November 17, 2025
Actual (reported)
Study Start
December 23, 2025
Actual (reported)
Primary Completion
October 26, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 31, 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: January 9, 2026
Status Verified: January 2026
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Taisho Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

RECRUITING

Taisho Director Taisho DirectorCONTACT81-3-3985-1118 shu_chiken@taisho.co.jp

Study Officials

Taisho Director Taisho Director
Taisho Pharmaceutical Co., Ltd.
STUDY DIRECTOR

Central Study Contacts

Taisho Pharmaceutical Co., Ltd.

CONTACT

81-3-3985-1118 shu_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

Actual (reported)

Primary Completion

October 26, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

NCT07285304

A Long-term Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis

Phase 3Recruiting

NCT06745518

A Phase 2 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders

Phase 2Completed

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.

Study Completion

October 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07231029
Data provider: ClinicalTrials.gov
Source updated: 2026-01-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:46 UTC

Locations

JP(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Mild hepatic impairment

Moderate hepatic impairment

Normal hepatic function

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations