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

JRCT ID: jRCT2031220463

Registered date:25/11/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Insomnia
• Date of first enrollment: 26/12/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Single oral dose of 5 mg of TS-142 (INN:vornorexant)

Outcome(s)

• Primary Outcome: Plasma concentration of unchanged form and its metabolites

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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 subjects 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.

Exclude 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 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.

Related Information

• Primary Sponsor: Mita Seiji
• Secondary ID(s): NCT05624944