Patients With Mild or Moderate Hepatic ImpairmentPhase 1NCT07231029
A Pharmacokinetic Study of TS-172 in Patients With Hepatic Impairment
A Phase 1 study testing TS-172 in people with Patients With Mild or Moderate Hepatic Impairment, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
An open-label study to evaluate the effect of TS-172 administration on pharmacokinetics in patients with hepatic impairment Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Mild or Moderate Hepatic Impairment
- What is being tested?
- TS-172
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 23 Dec 2025to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
<Inclusion criteria for patients with hepatic impairment>
- Japanese male and female patients whose age is >=18 and <=75 years at the time of obtaining informed consent
- Patients with chronic hepatic impairment
- 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>
- Japanese male and female patients whose age is >=18 and <=75 years at the time of obtaining informed consent
- 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>
- Patients with medical history of liver resection or liver transplantation
- Patients with grade II or higher hepatic encephalopathy
- 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>
- Subjects with current condition or medical history of diseases that are ineligible for participation in the study
- Subjects whose eGFR is <60 mL/min/1.73 m2 at screening test Other protocol defined exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Taisho Pharmaceutical Co., Ltd selected site
Tokyo
Taisho Director Taisho Director, 81-3-3985-1118, shu_chiken@taisho.co.jp
About this study
Official title: 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
- Being tested
- TS-172
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-172Drug
Single oral administration of TS-172 20mg
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impairment | Experimental | Not described Receives: Drug: TS-172 |
| Moderate hepatic impairment | Experimental | Not described Receives: Drug: TS-172 |
| Normal hepatic function | Experimental | Not described Receives: Drug: TS-172 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of unchanged form and metabolites
Measured: Up to 48 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start23 Dec 2025
- Primary completion26 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Mild or Moderate Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Director Taisho Director, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231029
- Sponsor's protocol ID
- TS172-03-10
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pharmacokinetic Study of TS-172 in Patients With Hepatic Impairment
- ClinicalTrials.gov ID
- NCT07231029
- Acronym / sponsor ID
- TS172-03-10
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 26 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label study to evaluate the effect of TS-172 administration on pharmacokinetics in patients with hepatic impairment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic impairment | Experimental | Drug: TS-172 |
| Moderate hepatic impairment | Experimental | Drug: TS-172 |
| Normal hepatic function | Experimental | Drug: TS-172 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TS-172Single oral administration of TS-172 20mg | Drug | Mild hepatic impairment, Moderate hepatic impairment, Normal hepatic function |
Primary outcome
Plasma concentrations of unchanged form and metabolites
Time frame: Up to 48 hours after dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taisho Director Taisho Director study director
Taisho Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TS-172 in people with Patients With Mild or Moderate Hepatic Impairment, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taisho Pharmaceutical Co., Ltd. (81-3-3985-1118, shu_chiken@taisho.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of unchanged form and metabolites (time frame: Up to 48 hours after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.