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New drug TS-172 tested in patients with liver impairment

NCT ID NCT07231029

Knowledge-focused Sponsor: Taisho Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study is testing how the drug TS-172 behaves in the bodies of people with mild or moderate liver impairment. Researchers will measure drug levels in the blood to see if liver function affects how the drug is processed. The study involves 24 Japanese adults and is currently recruiting participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TS-172

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

\<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.

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Conditions

The condition(s) this trial relates to.

liver disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Patients with mild or moderate hepatic impairment

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Taisho Pharmaceutical Co., Ltd selected site

    RECRUITING

    Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.