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

• Status: Not yet recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

1. Japanese male and female who are aged 18 to 75 years at the time of informed consent

2. Patients with cirrhosis

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.

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:

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.

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.