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

Taisho Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Patients With Mild or Moderate Hepatic Impairment

Treatments: Drug: TS-172

Study type: Interventional

Funder types: Industry

Identifiers

NCT07231029

TS172-03-10

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Mild hepatic impairment

Experimental group

Treatment:

Drug: TS-172

Moderate hepatic impairment

Experimental group

Treatment:

Drug: TS-172

Normal hepatic function

Experimental group

Treatment:

Drug: TS-172