A Food Effect Study of TS-142 in Healthy Subjects

JRCT ID: jRCT2071220103

Registered date:01/02/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Insomnia
• Date of first enrollment: 15/02/2023
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Single oral dose of 10 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: < 40age old
• Gender: Male

Include criteria

1.Japanese male who are aged 18 years or older but less than 40 years at the time of informed consent
2.Body Mass Index (BMI) of 18.5 or more and less than 25.0 at the screening test
3.Subjects who are judged by the investigators as an eligible for the clinical trial participation based on the screening tests and the tests conducted at treatment period 1.
Other protocol defined inclusion criteria could apply.

Exclude criteria

1.Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
2.Subjects who have any unsuitable medical history for participation in this study, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
3.Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts
Other protocol defined exclusion criteria could apply.

Related Information

• Primary Sponsor: Mita Seiji
• Secondary ID(s): NCT05707897