Patients with Mild Obstructive Sleep Apnea HypopneaPhase 1NCT04746105
A Clinical Pharmacology Study of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.
A Phase 1 study testing TS-142 in people with Patients with Mild Obstructive Sleep Apnea Hypopnea, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Patients with Mild Obstructive Sleep Apnea Hypopnea
- What is being tested?
- TS-142
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteJapan
- Study dates
- 24 Feb 2021to 30 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Respiratory Safety of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.
A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.
- Being tested
- TS-142, Dose-matched Placebo to TS-142
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-142Drug
Subjects received single-dose of 10 mg of TS-142 (oral tablet)
Dose-matched Placebo to TS-142Drug
Subjects received single-dose matched placebo to TS-142 (oral tablet)
| Study group | Role | What they receive |
|---|---|---|
| TS-142 | Experimental | Period in which subjects received TS-142 10 mg or The night when subjects received TS-142 Receives: Drug: TS-142 |
| Placebo | Experimental | Period in which subjects received placebo or The night when subjects received matched placebo Receives: Drug: Dose-matched Placebo to TS-142 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start24 Feb 2021
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients with Mild Obstructive Sleep Apnea HypopneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Direcoter, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746105
- Sponsor's protocol ID
- TS142-208
- Status last verified
- Nov 2021
- First submitted
- 5 Feb 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Respiratory Safety of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.
- ClinicalTrials.gov ID
- NCT04746105
- Acronym / sponsor ID
- TS142-208
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TS-142 | Experimental | Drug: TS-142Period in which subjects received TS-142 10 mg or The night when subjects received TS-142 |
| Placebo | Experimental | Drug: Dose-matched Placebo to TS-142Period in which subjects received placebo or The night when subjects received matched placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TS-142Subjects received single-dose of 10 mg of TS-142 (oral tablet) | Drug | TS-142 |
| Dose-matched Placebo to TS-142Subjects received single-dose matched placebo to TS-142 (oral tablet) | Drug | Placebo |
Primary outcome
Least square mean difference of Apnea hypopnea index (AHI) from placebo
Time frame: Day 1
AHI is a number of apnea and hypopnea events per hour during sleep determined by polyso㎜ography (PSG).
1 secondary outcome
Least square mean difference of the mean SpO2 in total sleep time from placebo
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taisho Direcoter study director
Taisho Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TS-142 in people with Patients with Mild Obstructive Sleep Apnea Hypopnea, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Least square mean difference of Apnea hypopnea index (AHI) from placebo (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.