Healthy SubjectsPhase 1NCT04873323
A QT/QTc Evaluation Study of TS-142 in Healthy Adult Subjects
A Phase 1 study testing TS-142 and Moxifloxacin in people with Healthy Subjects, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
A clinical study to evaluate the effects on QT/QTc Interval of TS-142 in Healthy Adult Subjects Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- TS-142 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteJapan
- Study dates
- 7 Jun 2021to 28 Sep 2021
- 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 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese Males or females aged 20 years or older but less than 40 years at the time of informed consent
- those with a BMI of 18.5 in male (17.6 in female) or more and less than 25.0 and a body weight of 40.0 kg or more at screening test
- those whose pulse rate measured by standard 12-lead ECG is 50 beats/min or more but no more than 90 beats/min at screening test and at the time before administration of investigational drug in period 1
- those who are judged eligible to participate in the study by the principal investigator or sub-investigator based on the results of screening test and test conducted before administration of investigational drug in period 1. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator or subinvestigator.
- those who are able to receive the explanation before participating in the study, understand the content of the study, and provide written informed consent by the subjects themselves.
Who cannot join
- Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator.
- Subjects with a medical history considered inappropriate for participation in the study, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrine, metabolic, hematological, immune, skin, neurological, and psychiatric diseases.
- Subjects with a history of drug allergy or food allergy.
- Subjects with a history of hypersensitivity to moxifloxacin or other quinolone antimicrobials
- Subjects with risk factors or with a history of risk factors for aortic aneurysm, aortic dissection (such as Marfan syndrome)
- Subjects with significant allergic predisposition (such as asthma requiring medical treatment)
Show all 13Show fewer
- Subjects with congenital disease, heart disease, or a history of heart disease
- Subjects with risk factors or with a history of risk factors for torsade de pointes (TdP) (heart failure, hypokalemia, family history of long QT syndrome, etc.)
- Subjects with a history of unconscious seizures suspected of involving TdP.
- Subjects with waveforms difficult to assess for QTc interval prolongation in standard 12-lead ECG at screening and the timing before administration of investigational product in period 1 (drift, electromyography contamination, T-wave geometry, marked sinus arrhythmia, frequent premature beats, etc.)
- Subjects with QTcF(Fridericia correction method) of at least 450 msec in men and at least 470 msec in women in standard-12-lead ECG at screening test and at the time before administration of investigational product in period 1.
- Subjects with suicidal ideation, suicide attempt on the Colombian Suicide Assessment Scale (C-SSRS) on Day-1 or a history of suicide attempt within the previous 5 years.
- Other protocol defined inclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effects on QT/QTc Interval of TS-142 in Healthy Adult Subjects
A clinical study to evaluate the effects on QT/QTc Interval of TS-142 in Healthy Adult Subjects
- Conditions
- Healthy Subjects
- Being tested
- TS-142, Moxifloxacin, 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 TS-142 10 mg or TS-142 30 mg in the morning under fasting in each period
MoxifloxacinDrug
Single dose of moxifloxacin 400 mg in the morning under fasting in each period
PlaceboDrug
Single dose of TS-142 placebo in the morning under fasting in each period
| Study group | Role | What they receive |
|---|---|---|
| TS-142 10 mg | Experimental | TS-142 therapeutic dose oral tablet (low dose) Receives: Drug: TS-142 |
| TS-142 30 mg | Experimental | Description: TS-142 supratherapeutic dose oral tablet (high dose) Receives: Drug: TS-142 |
| Moxifloxacin 400 mg | Experimental | Moxifloxacin tablet Receives: Drug: Moxifloxacin |
| Placebo | Experimental | Placebo oral tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTcF:QT-interval corrected by Fridericia corrections in Holter ECGs
Difference (ΔΔQTc) in change from baseline (ΔQTc) in QTc interval at each time point in each group compared with the placebo group
Measured: Up to 24 hours postdose during each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start7 Jun 2021
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Direcoter, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873323
- Sponsor's protocol ID
- TS142-209
- Status last verified
- Oct 2021
- First submitted
- 30 Apr 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Evaluate the Effects on QT/QTc Interval of TS-142 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04873323
- Acronym / sponsor ID
- TS142-209
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 5 May 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 effects on QT/QTc Interval of TS-142 in Healthy Adult 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-142TS-142 therapeutic dose oral tablet (low dose) |
| TS-142 30 mg | Experimental | Drug: TS-142Description: TS-142 supratherapeutic dose oral tablet (high dose) |
| Moxifloxacin 400 mg | Experimental | Drug: MoxifloxacinMoxifloxacin tablet |
| Placebo | Experimental | Drug: PlaceboPlacebo oral tablet |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Japanese Males or females aged 20 years or older but less than 40 years at the time of informed consent
- those with a BMI of 18.5 in male (17.6 in female) or more and less than 25.0 and a body weight of 40.0 kg or more at screening test
- those whose pulse rate measured by standard 12-lead ECG is 50 beats/min or more but no more than 90 beats/min at screening test and at the time before administration of investigational drug in period 1
- those who are judged eligible to participate in the study by the principal investigator or sub-investigator based on the results of screening test and test conducted before administration of investigational drug in period 1. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator or subinvestigator.
- those who are able to receive the explanation before participating in the study, understand the content of the study, and provide written informed consent by the subjects themselves.
Key exclusion criteria (13 listed)
- Subjects who have any disease and are not considered healthy subjects based on the medical judgment of the principal investigator or sub-investigator.
- Subjects with a medical history considered inappropriate for participation in the study, including respiratory, cardiovascular, gastrointestinal, hepatic, renal, urological, endocrine, metabolic, hematological, immune, skin, neurological, and psychiatric diseases.
- Subjects with a history of drug allergy or food allergy.
- Subjects with a history of hypersensitivity to moxifloxacin or other quinolone antimicrobials
- Subjects with risk factors or with a history of risk factors for aortic aneurysm, aortic dissection (such as Marfan syndrome)
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 TS-142 10 mg or TS-142 30 mg in the morning under fasting in each period | Drug | TS-142 10 mg, TS-142 30 mg |
| MoxifloxacinSingle dose of moxifloxacin 400 mg in the morning under fasting in each period | Drug | Moxifloxacin 400 mg |
| PlaceboSingle dose of TS-142 placebo in the morning under fasting in each period | Drug | Placebo |
Primary outcome
QTcF:QT-interval corrected by Fridericia corrections in Holter ECGs
Time frame: Up to 24 hours postdose during each period
Difference (ΔΔQTc) in change from baseline (ΔQTc) in QTc interval at each time point in each group compared with the placebo group
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 Direcoter 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 Moxifloxacin 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 5 inclusion and 13 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?
QTcF:QT-interval corrected by Fridericia corrections in Holter ECGs (time frame: Up to 24 hours postdose during each period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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; AzTrials last refreshed its copy on 7 Nov 2026.