Drug-drug interaction study with TS-142 in healthy adult subjects (concomitant administration of itraconazole)

JRCT ID: jRCT2071200036

Registered date:05/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Insomnia
• Date of first enrollment: 13/10/2020
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Oral administration by capsule of TS-142, strength at 1 or 5 mg

Outcome(s)

• Primary Outcome: Plasma concentration of compound(s)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 39age old
• Gender: Male

Include criteria

To be eligible for study participation, an individual must meet all of the following criteria:

- Japanese male age 20 to 39 years at the signing of informed consent
- Subjects whose body mass index (BMI) within the range 18.5 - 25.0 kg/m2, exclusive of 25.0
- Subjects who judged by the principal investigator(s) or subinvestigator(s) to be appropriate as a subjects of this study based on the results of screening tests and the tests obtained prior to the administration of the investigational drug. (Those who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test and the test obtained prior to administration of the investigational drug, and whose clinical test results are within the standard values of the clinical trial site. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator(s) or subinvestigator(s).)
- Subjects who understand, and have willingness and ability to read and sign, the informed consent form

Exclude criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

- Subjects who have any disease and are judged not to be healthy based on the medical viewpoints by the principal investigator(s) or subinvestigator(s)
- Subjects who have an inappropriate history for participation in this study, including hepatic, renal, cardiovascular, hematological, endocrinological, metabolic, respiratory, gastrointestinal, dermatological, neurological, urological, immunological, psychiatric abnormalities or diseases
- Subjects who have any history of drug or food allergies
- Other protocol defined exclusion criteria could apply

Related Information

• Primary Sponsor: Mita Seiji
• Secondary ID(s): NCT04557163