A QT/QTc evaluation study of TS-172 in healthy adult subjects

Taisho Pharmaceutical Co., LTD.0 个研究点目标入组 52 人开始时间: 2025年3月3日最近更新: 2025年6月5日

适应症

试验速览

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•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

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