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Completed

NCT Number: NCT04746105

A Clinical Pharmacology Study 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.

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Key information

Conditions

Patients with Mild Obstructive Sleep Apnea Hypopnea

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TS-142

Drug

Subjects received single-dose of 10 mg of TS-142 (oral tablet)

Dose-matched Placebo to TS-142

Drug

Subjects received single-dose matched placebo to TS-142 (oral tablet)

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Study to Evaluate the Respiratory Safety of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2021
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.