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An open-label pharmacokinetic study of TS-142 in patients with hepatic impairment

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

Mita Seiji

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

shu_chiken@taisho.co.jp

Development Headquarters Development Management

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

+81-3-3985-1118

shu_chiken@taisho.co.jp

Complete

Nov. 28, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

<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.

<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.

Both

Insomnia

Single oral dose of 5 mg of TS-142 (INN:vornorexant)

Plasma concentration of unchanged form and its metabolites

+81-42-625-5216

Nov. 25, 2022

No

none