Healthy SubjectsPhase 1NCT05819710
A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly 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.
Trial summary
This is a study to investigate the next-day residual effects of a single bedtime dosing of 5 mg and 10 mg of TS-142 in Japanese healthy elderly participants in double-blind manner. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy 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
- 43 participants
- Where
- 1 siteJapan
- Study dates
- 15 May 2023to 25 Aug 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects who are Japanese male or female aged 65 years or older at the time of obtaining informed consent
- Subjects with a body Mass Index (BMI) from 18.5 to less than 25.0 and a body weight of 40.0 kg or over at the screening test
- Subjects who are judged by the principal investigators or subinvestigators as an eligible for the clinical trial participation based on the results of tests conducted in the screening, VISIT 1 and prior to the administration of the investigational drug.
- Other protocol defined inclusion criteria could apply.
Who cannot join
- Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
- Subjects who have any unsuitable medical histories for participation in this clinical trial, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
- Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts.
- Other protocol defined exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
About this study
This is a study to investigate the next-day residual effects of a single bedtime dosing of 5 mg and 10 mg of TS-142 in Japanese healthy elderly participants in double-blind manner.
- 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
Single dose of 5 mg of TS-142
TS-142Drug
Single-dose of 10 mg of TS-142
ZopicloneDrug
Single-dose of 7.5 mg of zopiclone
PlaceboDrug
Single-dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| 5 mg of TS-142 | Experimental | Low dose of TS-142 Receives: Drug: TS-142 |
| 10 mg of TS-142 | Experimental | High dose of TS-142 Receives: Drug: TS-142 |
| 7.5 mg of Zopiclone | Experimental | Comparator. Receives: Drug: Zopiclone |
| Placebo | Experimental | Placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
RMS of COP in eye-open condition
the area of the circle whose radius is the root mean square (RMS) value of center of pressure (COP) calculated by the stabilometer in eye-open condition
Measured: 8 hour postdose
Secondary outcomes (3)
RMS of COP in eye-closed condition
the area of the circle whose radius is the root mean square (RMS) value of center of pressure (COP) calculated by the stabilometer in eye-closed condition
Measured: 8 hour postdose
Trajectory of COP in eye-open condition
the length of the total trajectory of center of pressure (COP) calculated by the stabilometer in eye-open condition
Measured: 8 hour postdose
Trajectory of COP in eye-closed condition
the length of the total trajectory of center of pressure (COP) calculated by the stabilometer in eye-closed condition
Measured: 8 hour postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start15 May 2023
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Director, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819710
- Sponsor's protocol ID
- TS142-305
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miyazaki Y, Kambe D, Imadera Y, Yamasaki H, Uchimura N, Uchiyama M. Comparison of next-morning residual effects by bedtime administration of vornorexant and zopiclone in healthy older participants: postural stability, neuropsychological functions, and subjective sleepiness in a randomized clinical study. Psychopharmacology (Berl). 2026 May 23. doi: 10.1007/s00213-026-07095-8. Online ahead of print.
PubMed 42174196
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 Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects
- ClinicalTrials.gov ID
- NCT05819710
- Acronym / sponsor ID
- TS142-305
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 19 Apr 2023 (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.
This is a study to investigate the next-day residual effects of a single bedtime dosing of 5 mg and 10 mg of TS-142 in Japanese healthy elderly participants in double-blind manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 mg of TS-142 | Experimental | Drug: TS-142Low dose of TS-142 |
| 10 mg of TS-142 | Experimental | Drug: TS-142High dose of TS-142 |
| 7.5 mg of Zopiclone | Experimental | Drug: ZopicloneComparator. |
| Placebo | Experimental | Drug: PlaceboPlacebo. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Subjects who are Japanese male or female aged 65 years or older at the time of obtaining informed consent
- Subjects with a body Mass Index (BMI) from 18.5 to less than 25.0 and a body weight of 40.0 kg or over at the screening test
- Subjects who are judged by the principal investigators or subinvestigators as an eligible for the clinical trial participation based on the results of tests conducted in the screening, VISIT 1 and prior to the administration of the investigational drug.
- Other protocol defined inclusion criteria could apply.
Key exclusion criteria (4 listed)
- Subjects who are judged to have any disease by the principal investigator or sub-investigator and are not considered healthy
- Subjects who have any unsuitable medical histories for participation in this clinical trial, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrinological, metabolic, hematologic, immunologic, dermatological, neurological, or psychiatric diseases
- Subjects who have any medical histories including sleep-associated symptoms, narcolepsy-like symptoms, suicidal ideation, or suicidal attempts.
- Other protocol defined exclusion criteria could apply.
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-142Single dose of 5 mg of TS-142 | Drug | 5 mg of TS-142 |
| TS-142Single-dose of 10 mg of TS-142 | Drug | 10 mg of TS-142 |
| ZopicloneSingle-dose of 7.5 mg of zopiclone | Drug | 7.5 mg of Zopiclone |
| PlaceboSingle-dose of placebo | Drug | Placebo |
Primary outcome
RMS of COP in eye-open condition
Time frame: 8 hour postdose
the area of the circle whose radius is the root mean square (RMS) value of center of pressure (COP) calculated by the stabilometer in eye-open condition
3 secondary outcomes
RMS of COP in eye-closed condition
Time frame: 8 hour postdose
Trajectory of COP in eye-open condition
Time frame: 8 hour postdose
Trajectory of COP in eye-closed condition
Time frame: 8 hour postdose
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.
- Derived from this study: PubMed 42174196Miyazaki Y, Kambe D, Imadera Y, Yamasaki H, Uchimura N, Uchiyama M. Comparison of next-morning residual effects by bedtime administration of vornorexant and zopiclone in healthy older participants: postural stability, neuropsychological functions, and subjective sleepiness in a randomized clinical study. Psychopharmacology (Berl). 2026 May 23. doi: 10.1007/s00213-026-07095-8. Online ahead of print.
- 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 4 inclusion and 4 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?
RMS of COP in eye-open condition (time frame: 8 hour postdose). 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 NCT05819710, which also lists 1 linked publication.
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.