A Clinical Pharmacology Study of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• 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

Exclusion 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