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

Patients With Mild Obstructive Sleep Apnea Hypopnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04746105
• Other study ID #: TS142-208
• Status: Completed
• Phase: Phase 1
• Start date: February 24, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: November 2021
• Source: Taisho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Patients With Mild Obstructive Sleep Apnea Hypopnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• TS-142
Subjects received single-dose of 10 mg of TS-142 (oral tablet)
• Dose-matched Placebo to TS-142
Subjects received single-dose matched placebo to TS-142 (oral tablet)

Locations

Country	Name	City	State
Japan	Taisho Pharmaceutical Co., Ltd selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 1
Secondary	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.	Day 1