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

Phase 1

Completed

• Conditions: Patients with Mild Obstructive Sleep Apnea Hypopnea
• Interventions: Drug: TS-142; Drug: Dose-matched Placebo to TS-142

• Registration Number: NCT04746105
• Lead Sponsor: Taisho Pharmaceutical Co., Ltd.

Brief Summary

A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-09
• Study Start: 2021-02-24
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Status Verified: 2021-11
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TS-142	TS-142	Period in which subjects received TS-142 10 mg or The night when subjects received TS-142
Placebo	Dose-matched Placebo to TS-142	Period in which subjects received placebo or The night when subjects received matched placebo

Primary Outcome Measures

Name	Time	Method
Least square mean difference of Apnea hypopnea index (AHI) from placebo	Day 1	AHI is a number of apnea and hypopnea events per hour during sleep determined by polyso㎜ography (PSG).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Tokyo, Japan