A Study to Evaluate Next Day Effects of TS-142 on Driving Performance in Healthy Subjects

Sponsor

Taisho Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04696952

Collaborator

(none)

Enrollment

Location

Arms

11.6

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A clinical study to evaluate the residual effects of TS-142 on driving performance in healthy and elderly subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: TS-142 Drug: Zopiclone Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Driving Performance Evaluation Study of TS-142 Using a Driving Simulator in Non-elderly and Elderly Healthy Subjects

Actual Study Start Date :

Jan 16, 2021

Actual Primary Completion Date :

Jan 5, 2022

Actual Study Completion Date :

Jan 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TS-142 10 mg Period in which subjects received TS-142 10 mg	Drug: TS-142 TS-142
Experimental: TS-142 20 mg Period in which subjects received TS-142 20 mg	Drug: TS-142 TS-142
Experimental: Zopiclone 7.5 mg Period in which subjects received Zopiclone 7.5 mg	Drug: Zopiclone Zopiclone
Experimental: Placebo Period in which subjects received placebo	Drug: Placebo Placebo

Outcome Measures

Primary Outcome Measures

Standard deviation of lateral position (SDLP) evaluated by using a driving simulator on day 2 [On day 2 at 9 hours post dose]
Standard deviation of lateral position (SDLP) evaluated by using a driving simulator on day 9 [On day 9 at 9 hours post dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Males and females aged 21 years or older but less than 80 years at the time of informed consent
Those with a BMI of 18.5 or more and less than 25.0 and a body weight of 40.0 kg or more at screening tests
Have an ordinary driving license and have driven on a daily basis for more than 3 years
Have a constant sleep pattern (waking up from 5:00 to 9:00, falling asleep from 21:00 to 1:00 and time in bed is from 6 to 8 hours)
No visual impairment (those who have >=0.7 vision in both eyes and >=0.3 in each eye at vision test of screening tests, enable to correct the vision with eyeglasses or contact lens)
Those who have cognitive and physical function (adequate dexterity of fingers, vision and hearing etc.) to operate Driving Simulator (DS) certainly, understand and carry out the direction on the task of the DS evaluation
Those with no abnormal findings in medical examinations, vital signs, or 12-lead electrocardiogram and whose laboratory test results were within the reference values of the study site based on the results of screening tests and tests obtained before hospitalization of Visit 1
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Those who have any disease and are not regarded as healthy subjects based on the medical judgment of the principal investigator or sub-investigator
Those who have a medical history that makes them ineligible for participation in this study such as respiratory disease, cardiovascular disease, gastrointestinal disease, liver disorder, renal disorder, urological disease, endocrine disease, metabolic disease, hematological disease, immune disease, skin disease, neurological disease, mental disorder etc.
Those who have had symptoms of parasomnia (parasomnia, sleepwalking, abnormal dreams, nightmares), narcolepsy-like symptoms (cataplexy, hypnagogic hallucinations, sleep paralysis), or suicide attempt
Those who have hypersensitivity to zopiclone or s-zopiclone
Those who have experienced a time difference of 6 hours or more within 1 week prior to Visit 1, or who will be exposed to such time difference during the study period
Those who have performed irregular shift work or night shift work within 4 weeks prior to Visit 1, or need to do so during the study period
Those who have performed the DS evaluation used in this clinical trial in the past
Those who received TS-142 (active drug) in the past
Those who go of course even once at the DS evaluation in Visit1
Those whose total SDLP in 60 minutes at the DS evaluation in Visit1 is more than 60 cm
Other protocol defined exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taisho Pharmaceutical Co., Ltd selected site	Tokyo		Japan

Sponsors and Collaborators

Taisho Pharmaceutical Co., Ltd.

Investigators

Study Director: Taisho Director, Taisho Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taisho Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04696952

Other Study ID Numbers:

TS142-207

First Posted:

Jan 6, 2021

Last Update Posted:

Jan 13, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Zopiclone

Study Results

No Results Posted as of Jan 13, 2022