A Randomized, Placebo-Controlled, Four-Period Crossover Definitive QT Study Of The Effects of APF530 Exposure, High-Dose IV Granisetron and Moxifloxacin on QTc Prolongation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- QTc Prolongation
研究概览
简要总结
This Phase I study will be performed in a double-blind, randomized, crossover design in healthy male and female subjects. The central ECG laboratory will be blinded to treatment. Every effort will be made to enroll equal numbers of males and females into the study.
Eligible subjects will participate in a screening phase (within 28 days of the dosing day), a treatment phase and a final visit, which will be conducted on discharge from the study. Study duration will be 32 days with a total of approximately 12 days of confinement. During the resting ECG periods, 12-lead digital ECGs will be extracted from continuous telemetry at selected time points to assess potential ECG effects. Blood samples for PK evaluation will be collected in conjunction with the ECG time points.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects in good health
- •aged between 18-50 years
- •weigh at least 50 kg (110 pounds)
- •have a body mass index of 18-32 kg/m2 inclusive
- •capable of understanding and complying with the protocol
- •have signed the informed consent
排除标准
- •have a history of drug abuse or are current smokers
- •have a known hypersensitivity to Moxifloxacin or granisetron
- •a history or presence of clinically significant abnormal 12-lead ECG or an ECG with QTc by Bazett's correction of > 450 ms in men, > 470 ms in women on the screening ECG
- •PR > 240 ms, QRS > 110 ms or a history of prolongation of QT interval
- •a family history of Long QT Syndrome or cardiac disease
- •may not have used any medications or consumed any foods contraindicated in the protocol
研究组 & 干预措施
APF530 Exposure, Granisetron and Moxifloxacin, Placebo
Arm 1:APF530 Exposure Arm 2:Granisetron IV Arm 3:Moxifloxacin Arm 4:Placebo
干预措施: Withdraw treatment (Drug)
结局指标
主要结局
QTc Prolongation
时间窗: From baseline over 48 hours.
To evaluate the effect of APF530 given subcutaneously, in normal volunteers, on placebo subtracted change of QTcF
次要结局
- Plasma concentrations of granisetron(From baseline over 48 hours)