A Thorough QT/QTc Study of TAS-205 in Healthy Male Adult Subjects

Taiho Pharmaceutical Co., Ltd.0 个研究点目标入组 60 人开始时间: 待定最近更新: 2025年2月20日

试验速览

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•Healthy Japanese male who has given written consent to participate in this study
•18 to 40 years of age at the time of consent
•weigh 50 kg or more but less than 90 kg at screening and have a body mass index (BMI) {body mass [kg]/(height [m])2} of 18.0 or more
•Body mass index (BMI) {body weight [kg]/(height [m])2} is between 18.0 and 25.0
•Vital signs at the time of screening are as follows
•Systolic blood pressure (supine): 90 mmHg to less than 140 mmHg
•Diastolic blood pressure (supine): 40 mmHg to less than 90 mmHg
•Pulse rate: 40 beats/minute to less than 100 beats/minute
•Body temperature: 35.0 degrees Celsius to less than 37.4 degrees Celsius
•Oral administration of the investigational drug is allowed.
•Willing and able to comply with the visit schedule and study procedures specified in this study.

•A QTcF interval of 450 msec or more based on a resting 12-lead ECG at screening.
•Clinically significant abnormality on resting 12-lead ECG at screening.
•Risk factors for Torsades de pointes (heart failure, hypokalemia, or QT prolongation syndrome, etc.)
•History of ventricular arrhythmias (except occasional ventricular extrasystoles)
•Use of a pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization device

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