How TS-172 is processed in people with liver impairment

An Open-label Pharmacokinetic Study of TS-172 in Patients With Hepatic Impairment

This trial will test how the body handles the drug TS-172 in adults with mild or moderate liver impairment compared with adults who have normal liver function.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Taisho Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Tokyo)
• Trial ID: NCT07231029 on ClinicalTrials.gov

What this trial studies

This open-label Phase 1 study gives TS-172 to Japanese adults with chronic mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment and to matched subjects with normal liver function, then measures blood levels over time to characterize pharmacokinetics. Key inclusion criteria are age 18–75 and documented chronic hepatic impairment for the affected group, while major exclusions include prior liver resection or transplant, grade II or higher hepatic encephalopathy, and reduced kidney function (eGFR <45 mL/min/1.73m2). The study is sponsored by Taisho Pharmaceutical and conducted at a company-selected site in Tokyo. Results will inform how liver impairment affects TS-172 exposure and may guide dosing recommendations.

Who should consider this trial

Good fit: Ideal candidates are Japanese adults aged 18–75 with chronic mild or moderate hepatic impairment (Child-Pugh A or B) or otherwise healthy Japanese adults meeting the normal-function control criteria (BMI 18.5–<35).

Not a fit: Patients with severe hepatic impairment (Child-Pugh C), prior liver resection or transplant, significant hepatic encephalopathy, eGFR below 45 mL/min/1.73m2, or those who are not eligible by the protocol are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could help set safer, evidence-based dosing recommendations for people with liver impairment who might take TS-172.

How similar studies have performed: Pharmacokinetic studies in people with hepatic impairment are a standard approach and have successfully guided dosing and safety labeling for many other drugs.

Eligibility criteria

\<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.

Where this trial is running

Tokyo

• Taisho Pharmaceutical Co., Ltd selected site — Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: Taisho Pharmaceutical Co., Ltd.

Conditions Patients With Mild or Moderate Hepatic Impairment