A Pharmacokinetic Study of TS-142 in Patients with Hepatic Impairment

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Patients with Mild or Moderate Hepatic Impairment

Treatments: Drug: TS-142 5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05624944

TS142-303

Details and patient eligibility

About

This is an open-label pharmacokinetic study of TS-142 in patients with hepatic impairment

Enrollment: 84 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

<Inclusion criteria for patients with hepatic impairment>

1. Japanese male and female who are aged 18 to 75 years at the time of informed consent
2. Patients with cirrhosis or chronic hepatic impairment
3. Patients classified as Child-Pugh classification A (mild) or B (moderate) by the principal investigator or sub-investigator at the screening test Other protocol defined inclusion criteria could apply.

<Inclusion criteria for subject with normal hepatic function>

1. Japanese male and female who are aged 18 to 75 years at the time of informed consent
2. Body Mass Index (BMI) between 18.5 and 35.0 at the screening test Other protocol defined inclusion criteria could apply.

Exclusion criteria

<Exclusion criteria for patients with hepatic impairment>

1. Patients who have a history of liver resection or liver transplant
2. Patients with hepatic encephalopathy of grade II or higher
3. Patients with epidermal growth factor receptor (eGFR) less than 45 mL/min/1.73 m2 at the screening test Other protocol defined exclusion criteria could apply.

<Exclusion criteria for subjects with normal hepatic function>

1. Subjects who are judged to have any disease by the principal investigator or sub-investigator
2. Subjects with eGFR less than 60 mL/min/1.73 m2 at the 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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84 participants in 3 patient groups

Mild hepatic impairment

Experimental group

Description:

Patients with mild hepatic impairment will receive a single-dose of 5 mg of TS-142

Treatment:

Drug: TS-142 5 mg

Moderate hepatic impairment

Experimental group

Description:

Patients with moderate hepatic impairment will receive a single-dose of 5 mg of TS-142

Treatment:

Drug: TS-142 5 mg

Normal hepatic function

Experimental group

Description:

Subjects with normal hepatic function will receive a single-dose of 5 mg of TS-142

Treatment:

Drug: TS-142 5 mg