Patients with Mild Obstructive Sleep Apnea Hypopnea
Conditions
Brief summary
A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.
Interventions
DRUGTS-142
Subjects received single-dose of 10 mg of TS-142 (oral tablet)
Subjects received single-dose matched placebo to TS-142 (oral tablet)
Sponsors
Taisho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least square mean difference of Apnea hypopnea index (AHI) from placebo | Day 1 | AHI is a number of apnea and hypopnea events per hour during sleep determined by polyso㎜ography (PSG). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Least square mean difference of the mean SpO2 in total sleep time from placebo | Day 1 | The SpO2 will be simultaneously measured with PSG. The mean SpO2 during sleep determined by PSG will be calculated. |
Countries
Japan
Outcome results
None listed