A QT/QTc Evaluation Study of TS-172 in Healthy Adult Subjects (NCT06837155) | Clinical Trial Compass
CompletedPhase 1
A QT/QTc Evaluation Study of TS-172 in Healthy Adult Subjects
Japan52 participantsStarted 2025-03-03
Plain-language summary
A clinical study to evaluate the effects on QT/QTc interval of TS-172 in healthy adults subjects
Who can participate
Age range
18 Years – 39 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
QTcF:QT-interval corrected by Fridericia corrections in Holter ECGs
Timeframe: Up to 24 hours postdose during each period
. 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