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

Phase 1

Completed

• Conditions: Patients with Mild or Moderate Hepatic Impairment
• Interventions: Drug: TS-142 5 mg

• Registration Number: NCT05624944
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-20
• Study First Posted: 2022-11-22
• Status Verified: 2022-12
• Study Start: 2022-12-26
• Primary Completion: 2023-12-05
• Study Completion: 2023-12-05
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild hepatic impairment	TS-142 5 mg	Patients with mild hepatic impairment will receive a single-dose of 5 mg of TS-142
Normal hepatic function	TS-142 5 mg	Subjects with normal hepatic function will receive a single-dose of 5 mg of TS-142
Moderate hepatic impairment	TS-142 5 mg	Patients with moderate hepatic impairment will receive a single-dose of 5 mg of TS-142

Primary Outcome Measures

Name	Time	Method
Plasma concentration	Predose and up to 48 hours postdose	Plasma concentration of unchanged form and its metabolite
Pharmacokinetic parameters	Predose and up to 48 hours postdose	Apparent total body clearance adjusted by unbound fraction of unchanged form (CL(unbound)/F)

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	From administration of investigational product through 10 days after administration of investigational product	"Adverse event" refers to any unfavorable or unintended disease or symptom thereof (including abnormal laboratory tests values) occurring in a subject who has been administered an investigational product, whether or not there is a causal relationship with the investigational product.

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Tokyo, Japan