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

Age range18 Years – 39 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

QTcF:QT-interval corrected by Fridericia corrections in Holter ECGs

Timeframe: Up to 24 hours postdose during each period

NCT IDNCT06837155

SponsorTaisho Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-20

Who can participate

Age range18 Years – 39 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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