KRP-AM1977X Phase I Clinical Study-To assess the effect of KRP-AM1977X on QT/QTc interval in healthy Japanese male subjects

Kyorin Pharmaceutical Co., Ltd.0 个研究点目标入组 60 人开始时间: 2015年9月7日最近更新: 2023年10月17日

研究概览

简要总结

AM-1977 was evaluated for QT/QTc prolongation in single oral doses of 225 mg, 450 mg and 750 mg, with the 225 mg dose being negative and the 450 mg dose being positive. There was a positive correlation between AM-1977 plasma concentration and Double-Delta QTcF.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 <= 40age old（—）
性别: Male

入选标准

•Japanese healthy adult male
•- Person with BMI that is more than 18.5 but less than 25.0, etc.

排除标准

•Healthy male subject with an inadequate medical history

研究者

发起方

Kyorin Pharmaceutical Co., Ltd.

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