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A clinical pharmacology study of TS-142 in patients with obstructive sleep apnea hypopnea.

A clinical pharmacology study of TS-142 in patients with obstructive sleep apnea hypopnea.

46

Age (years): Mean+-SD 47.4+-14.0, Body Weight (kg): Mean+-SD 69.77+-8.78, Sex (%): Female 19.6, Duration of obstructive sleep apnea hypopnea (years): 0.85+-3.43

46 subjects were randomized to any of the arms, and received the investigational products once or more. 44 subjects completed, and 2 subjects discontinued the study.

The upper limit of 90% confidence interval of the AHI difference with placebo (primary endpoint), was less than 5 in TS-142 10 mg group.

The upper limit of 90% confidence interval of the AHI difference with placebo (primary endpoint), was less than 5 in TS-142 10 mg group.

Single dose of TS-142 10 mg did not show clinically significant effects on respiratory function in patients with mild obstructive sleep apnea hypopnea. No clinically relevant safety concerns were observed in TS-142 group.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031200373

Mita Seiji

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

shu_chiken@taisho.co.jp

Development Management Development Headquarters

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

+81-3-3985-1118

shu_chiken@taisho.co.jp

Complete

Feb. 22, 2021

Interventional

randomized controlled trial

double blind

placebo control

crossover assignment

other

Subjects must meet all of the following criteria to be included in this study:

- 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

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

Both

Obstructive sleep apnea hypopnea

Single oral doses of 10 mg of TS-142 and matching placebo

Apnea hypopnea index

Saturation of percutaneous oxygen

+81-3-5396-4530

Feb. 04, 2021

none