Healthy SubjectsPhase 1NCT04696952

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

A Phase 1 study testing TS-142 and Zopiclone in people with Healthy Subjects, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 21 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: TS-142 and Zopiclone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 61 participants
Where: 1 siteJapan
Study dates: 16 Jan 2021to 5 Jan 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Taisho Pharmaceutical Co., Ltd selected site
Tokyo

Other trials in Japan

About this study

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

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

Conditions: Healthy Subjects
Being tested: TS-142, Zopiclone, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TS-142Drug
TS-142
ZopicloneDrug
Zopiclone
PlaceboDrug
Placebo

Study groups in NCT04696952
Study group	Role	What they receive
TS-142 10 mg	Experimental	Period in which subjects received TS-142 10 mg Receives: Drug: TS-142
TS-142 20 mg	Experimental	Period in which subjects received TS-142 20 mg Receives: Drug: TS-142
Zopiclone 7.5 mg	Experimental	Period in which subjects received Zopiclone 7.5 mg Receives: Drug: Zopiclone
Placebo	Experimental	Period in which subjects received placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jan 20215 Jan 2022

First posted6 Jan 2021
Study start16 Jan 2021
Primary completion5 Jan 2022
Study completion5 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04696952
Sponsor's protocol ID: TS142-207
Status last verified: Jan 2022
First submitted: 18 Dec 2020
Last updated: 28 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Driving Performance Evaluation Study of TS-142 Using a Driving Simulator in Non-elderly and Elderly Healthy Subjects
ClinicalTrials.gov ID: NCT04696952
Acronym / sponsor ID: TS142-207
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 16 Jan 2021 (actual)
Primary completion: 5 Jan 2022 (actual)
Study completion: 5 Jan 2022 (actual)
First posted: 6 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
TS-142 10 mg	Experimental	Drug: TS-142Period in which subjects received TS-142 10 mg
TS-142 20 mg	Experimental	Drug: TS-142Period in which subjects received TS-142 20 mg
Zopiclone 7.5 mg	Experimental	Drug: ZopiclonePeriod in which subjects received Zopiclone 7.5 mg
Placebo	Experimental	Drug: PlaceboPeriod in which subjects received placebo

Who may qualify

Ages: 21 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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)

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TS-142TS-142	Drug	TS-142 10 mg, TS-142 20 mg
ZopicloneZopiclone	Drug	Zopiclone 7.5 mg
PlaceboPlacebo	Drug	Placebo

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Taisho Director study director

Taisho Pharmaceutical Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TS-142 and Zopiclone in people with Healthy Subjects, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standard deviation of lateral position (SDLP) evaluated by using a driving simulator on day 2 (time frame: On day 2 at 9 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04696952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.