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

February 26, 2025 updated by: Taisho Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Taisho Pharmaceutical Co., Ltd selected site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TS-142
Period in which subjects received TS-142 10 mg or The night when subjects received TS-142
Drug: TS-142
Subjects received single-dose of 10 mg of TS-142 (oral tablet)
Experimental: Placebo
Period in which subjects received placebo or The night when subjects received matched placebo
Drug: Dose-matched Placebo to TS-142
Subjects received single-dose matched placebo to TS-142 (oral tablet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Least square mean difference of the mean SpO2 in total sleep time from placebo
Time Frame: Day 1
The SpO2 will be simultaneously measured with PSG. The mean SpO2 during sleep determined by PSG will be calculated.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taisho Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Taisho Direcoter, Taisho Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2021

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TS142-208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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