NCT04746105

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

February 24, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

February 28, 2025

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

February 5, 2021

Last Update Submit

February 26, 2025

Conditions

Patients with Mild Obstructive Sleep Apnea Hypopnea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Least square mean difference of the mean SpO2 in total sleep time from placebo

    Day 1

Study Arms (2)

TS-142

EXPERIMENTAL

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

Drug: TS-142

Placebo

EXPERIMENTAL

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

Drug: Dose-matched Placebo to TS-142

Interventions

TS-142DRUG

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

TS-142
Dose-matched Placebo to TS-142DRUG

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

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

MeSH Terms

Interventions

TS-142

Study Officials

  • Taisho Direcoter

    Taisho Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 9, 2021

Study Start

February 24, 2021

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

February 28, 2025

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)