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

NCT04696952 | Completed Phase 1

• 1 other identifier: TS142-207
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

TS-142 10 mg

EXPERIMENTAL

Period in which subjects received TS-142 10 mg

Drug: TS-142

TS-142 20 mg

EXPERIMENTAL

Period in which subjects received TS-142 20 mg

Drug: TS-142

Zopiclone 7.5 mg

EXPERIMENTAL

Period in which subjects received Zopiclone 7.5 mg

Drug: Zopiclone

Placebo

EXPERIMENTAL

Period in which subjects received placebo

Drug: Placebo

Interventions

TS-142 DRUG

TS-142

TS-142 10 mg; TS-142 20 mg

Zopiclone DRUG

Zopiclone

Zopiclone 7.5 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taisho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan

Location

MeSH Terms

Interventions

TS-142; zopiclone

Study Officials

• Taisho Director

  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: December 18, 2020
• First Posted: January 6, 2021
• Study Start: January 16, 2021
• Primary Completion: January 5, 2022
• Study Completion: January 5, 2022
• Last Updated: February 28, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)