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

Taisho Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Patients with Mild Obstructive Sleep Apnea Hypopnea

Treatments: Drug: TS-142; Drug: Dose-matched Placebo to TS-142

Study type: Interventional

Funder types: Industry

Identifiers

NCT04746105

TS142-208

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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46 participants in 2 patient groups

TS-142

Experimental group

Description:

Period in which subjects received TS-142 10 mg or The night when subjects received TS-142

Treatment:

Drug: TS-142

Placebo

Experimental group

Description:

Period in which subjects received placebo or The night when subjects received matched placebo

Treatment:

Drug: Dose-matched Placebo to TS-142