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

A Driving Performance Evaluation Study of TS-142

61

Age (years): Mean+-SD 47.7+-15.4, Body Weight (kg): Mean+-SD 62.53+-7.55, Sex (%): Female 31.7, Elderly (%): 21.7

61 subjects were randomized and allocated to 4 sequences, then received investigational product once or more. 6 subjects were discontinued. 55 subjects in Placebo group, 56 in TS-142 10 mg group, 57 in TS-142 20 mg group, and 55 in zopiclone group completed this study.

The adverse events were observed in 7 of 56 subjects(12.5%)in Placebo group, 13 of 57(22.8%)in TS-142 10 mg group, 15 of 58(25.9%)in TS-142 20 mg group, and 12 of 58(20.7%)in zopiclone group.

The upper limit of 90% CI of the difference with placebo for standard deviation of lateral position (primary endpoint) was less than clinically significant threshold in TS-142 10 mg group and 20 mg group at Day 2 and 9.

Single and repeated doses of TS-142 10 mg and 20 mg did not have clinically significant effects on driving performance in healthy non-elderly and elderly subjects.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071200075

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

Jan. 16, 2021

Interventional

randomized controlled trial

double blind

placebo control

crossover assignment

other

- 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

- 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

Both

Healthy adult and elderly

Drug, Driving simulator, Blood sampling

Standard Deviation of Lateral Position (SDLP)

Sleep questionnaire etc

+81-92-283-7701

Jan. 15, 2021

none