Healthy VolunteersPhase 1NCT06837155
A QT/QTc Evaluation Study of TS-172 in Healthy Adult Subjects
A Phase 1 study testing TS-172 20 mg, TS-172 90 mg and Moxifloxacin in people with Healthy Volunteers, 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-172 in healthy adults subjects Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TS-172 20 mg, TS-172 90 mg and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteJapan
- Study dates
- 3 Mar 2025to 26 May 2025
- 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 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese healthy subjects aged =>18 and <40 years at the time of obtaining informed consent
- Subjects whose body weight is >=40 kg at the screening test, and body mass index is >=18.5 and <25.0
- Subjects with both heart rates are =>45 and =<100 beats/min on a standard 12-lead electrocardiogram at the screening test and before drug administration in Period 1
Who cannot join
- Subjects with a history of hypersensitivity to moxifloxacin or other quinolone antibiotics
- Subjects with a family history or risk factors for aortic aneurysm or aortic dissection (e.g., Marfan syndrome)
- Subjects with a family history of sudden death
- Subjects with congenital diseases, heart diseases, or medical history of such conditions
- Subjects with risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, or a family history of long QT syndrome) or medical history of such conditions
- Subjects with medical history of syncope suspected to be related to TdP, unexplained syncope, or seizures
- Subjects with standard 12-lead electrocardiogram waveforms that make it difficult to evaluate QTc prolongation (e.g., drift, EMG interference, T wave morphology, significant sinus arrhythmia, or frequent ectopic beats) at the screening and before the administration of the study drug in Period 1
- Subjects with a QTcF (QT interval corrected using Fridericia's formula) of =>450 msec in the standard 12-lead ECG test at the screening and before the administration of the study drug in Period 1
Trial locations and contacts
1 site in 1 country.
About this study
A clinical study to evaluate the effects on QT/QTc interval of TS-172 in healthy adults subjects
- Conditions
- Healthy Volunteers
- Being tested
- TS-172 20 mg, TS-172 90 mg, Moxifloxacin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-172 20 mgDrug
oral administration of TS-172 20 mg
TS-172 90 mgDrug
oral administration of TS-172 90 mg
MoxifloxacinDrug
oral administration of moxifloxacin 400 mg
PlaceboDrug
oral administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| TS-172 20 mg | Experimental | Not described Receives: Drug: TS-172 20 mg |
| TS-172 90 mg | Experimental | Not described Receives: Drug: TS-172 90 mg |
| Moxifloxacin | Active comparator | Not described Receives: Drug: Moxifloxacin |
| Placebo | Placebo comparator | Not described 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
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 posted20 Feb 2025
- Study start3 Mar 2025
- Primary completion20 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837155
- Sponsor's protocol ID
- TS172-03-07
- Status last verified
- Jun 2025
- First submitted
- 16 Feb 2025
- Last updated
- 6 Jun 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A QT/QTc Evaluation Study of TS-172 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06837155
- Acronym / sponsor ID
- TS172-03-07
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 20 Feb 2025 (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-172 in healthy adults subjects
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 |
|---|---|---|
| TS-172 20 mg | Experimental | Drug: TS-172 20 mg |
| TS-172 90 mg | Experimental | Drug: TS-172 90 mg |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Japanese healthy subjects aged =>18 and <40 years at the time of obtaining informed consent
- Subjects whose body weight is >=40 kg at the screening test, and body mass index is >=18.5 and <25.0
- Subjects with both heart rates are =>45 and =<100 beats/min on a standard 12-lead electrocardiogram at the screening test and before drug administration in Period 1
Key exclusion criteria (8 listed)
- Subjects with a history of hypersensitivity to moxifloxacin or other quinolone antibiotics
- Subjects with a family history or risk factors for aortic aneurysm or aortic dissection (e.g., Marfan syndrome)
- Subjects with a family history of sudden death
- Subjects with congenital diseases, heart diseases, or medical history of such conditions
- Subjects with risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, or a family history of long QT syndrome) or medical history of such conditions
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-172 20 mgoral administration of TS-172 20 mg | Drug | TS-172 20 mg |
| TS-172 90 mgoral administration of TS-172 90 mg | Drug | TS-172 90 mg |
| Moxifloxacinoral administration of moxifloxacin 400 mg | Drug | Moxifloxacin |
| Placebooral administration of placebo | Drug | Placebo |
Primary outcome
QTcF:QT-interval corrected by Fridericia corrections in Holter ECGs
Time frame: Up to 24 hours postdose during each period
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 6 Jun 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
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-172 20 mg, TS-172 90 mg and Moxifloxacin in people with Healthy Volunteers, 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 3 inclusion and 8 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 6 Jun 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. Some participants in this study may receive a placebo. 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 6 Jun 2025.