A Clinical Pharmacology Study of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.
NCT ID: NCT04746105
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2021-02-24
2021-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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TS-142
Period in which subjects received TS-142 10 mg or The night when subjects received TS-142
TS-142
Subjects received single-dose of 10 mg of TS-142 (oral tablet)
Placebo
Period in which subjects received placebo or The night when subjects received matched placebo
Dose-matched Placebo to TS-142
Subjects received single-dose matched placebo to TS-142 (oral tablet)
Interventions
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TS-142
Subjects received single-dose of 10 mg of TS-142 (oral tablet)
Dose-matched Placebo to TS-142
Subjects received single-dose matched placebo to TS-142 (oral tablet)
Eligibility Criteria
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Inclusion Criteria
* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for obstructive sleep apnea hypopnea
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Taisho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Taisho Direcoter
Role: STUDY_DIRECTOR
Taisho Pharmaceutical Co., Ltd.
Locations
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Taisho Pharmaceutical Co., Ltd selected site
Tokyo, , Japan
Countries
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Other Identifiers
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TS142-208
Identifier Type: -
Identifier Source: org_study_id
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