Back to resultsA Clinical Pharmacology Study of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.
Primary Purpose
Patients With Mild Obstructive Sleep Apnea Hypopnea
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
TS-142
Dose-matched Placebo to TS-142
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Mild Obstructive Sleep Apnea Hypopnea
Eligibility 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
Sites / Locations
- Taisho Pharmaceutical Co., Ltd selected site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TS-142
Placebo
Arm Description
Period in which subjects received TS-142 10 mg or The night when subjects received TS-142
Period in which subjects received placebo or The night when subjects received matched placebo
Outcomes
Primary Outcome Measures
Least square mean difference of Apnea hypopnea index (AHI) from placebo
AHI is a number of apnea and hypopnea events per hour during sleep determined by polyso㎜ography (PSG).
Secondary Outcome Measures
Least square mean difference of the mean SpO2 in total sleep time from placebo
The SpO2 will be simultaneously measured with PSG. The mean SpO2 during sleep determined by PSG will be calculated.
Full Information
NCT ID
NCT04746105
First Posted
February 5, 2021
Last Updated
October 5, 2022
Sponsor
Taisho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04746105
Brief Title
A Clinical Pharmacology Study of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.
Official Title
A Study to Evaluate the Respiratory Safety of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taisho Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Mild Obstructive Sleep Apnea Hypopnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TS-142
Arm Type
Experimental
Arm Description
Period in which subjects received TS-142 10 mg or The night when subjects received TS-142
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Period in which subjects received placebo or The night when subjects received matched placebo
Intervention Type
Drug
Intervention Name(s)
TS-142
Intervention Description
Subjects received single-dose of 10 mg of TS-142 (oral tablet)
Intervention Type
Drug
Intervention Name(s)
Dose-matched Placebo to TS-142
Intervention Description
Subjects received single-dose matched placebo to TS-142 (oral tablet)
Primary Outcome Measure Information:
Title
Least square mean difference of Apnea hypopnea index (AHI) from placebo
Description
AHI is a number of apnea and hypopnea events per hour during sleep determined by polyso㎜ography (PSG).
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Least square mean difference of the mean SpO2 in total sleep time from placebo
Description
The SpO2 will be simultaneously measured with PSG. The mean SpO2 during sleep determined by PSG will be calculated.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taisho Direcoter
Organizational Affiliation
Taisho Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Taisho Pharmaceutical Co., Ltd selected site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Pharmacology Study of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.
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