JPRN-jRCT2080223877已完成1 期
A Single-center, Randomized, Double-blind (for OPC-61815 and Placebo), Placebo- and Moxifloxacin Positive-controlled, 4-Period Crossover Trial to Evaluate the Effect of Single Intravenous Administration of OPC-61815 at 16 and 32 mg on QT/QTc Interval in Healthy Male Subjects.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
There was no QTcF prolongation after dosing with OPC-61815. No deaths, other serious TEAEs, and TEAEs leading to discontinuation of the IMP occurred in this trial. Furthermore, no TEAEs relating to ECG findings were reported for any subject. The above results demonstrated 1-hour intravenous administration of OPC-61815 at 16 and 32 mg were well tolerated.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 45age old（—）
- 性别
- Male
入选标准
- •1) Body mass index (BMI) [body weight in kg / (height in m)2] of at least 18.5 kg/m2 and less than 25.0 kg/m2 as a result of at the screening examination
- •2) Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to start of any trial-related procedures and capable of complying with the procedures for this trial
排除标准
- •1) Subjects with a medical history of convulsive disorder, long QT syndrome (including family history), syncope
- •during swimming, or any other type of syncope or cryptogenic loss of consciousness
- •2) Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia, hypocalcemia, etc)
- •3) Subjects with a family history of sudden death
研究者
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