A pharmacokinetic study of TS-142 in patients with hepatic impairment

Phase 1

• Conditions: Insomnia

• Registration Number: JPRN-jRCT2031220463
• Lead Sponsor: Mita Seiji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-25
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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.

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified