A clinical pharmacology study of TS-142 in patients with obstructive sleep apnea hypopnea.

JRCT ID: jRCT2031200373

Registered date:19/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Obstructive sleep apnea hypopnea
• Date of first enrollment: 24/02/2021
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Single oral doses of 10 mg of TS-142 and matching placebo

Outcome(s)

• Primary Outcome: Apnea hypopnea index
• Secondary Outcome: Saturation of percutaneous oxygen

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Subjects must meet all of the following criteria to be included in this study:

- Japanese male and female, age 20 years or older at the time of informed consent
- Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for obstructive sleep apnea hypopnea
- Other protocol defined inclusion criteria could apply

Exclude criteria

Subjects who meet any of the following criteria will be excluded from this study:

- Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting obstructive sleep apnea hypopnea and insomnia disorder
- Patients who have clinically significant respiratory dysfunction (bronchiectasis, emphysema, asthma, etc.) other than obstructive sleep apnea hypopnea
- Patients with percutaneous arterial oxygen saturation (SpO2) <94% by pulse oximetry at visit 1
- Other protocol defined exclusion criteria could apply

Related Information

• Primary Sponsor: Mita Seiji
• Secondary ID(s): NCT04746105