A Comparative, Proof of Concept Study, Comprising of a Pilot Phase Bioavailability Study Part and a Randomised, Cross-over Food-effect Study Part of "XS003" and Originator in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Bioavailability of Nilotinib
研究概览
简要总结
The study will assess bioavailability of XS003 given as a single oral dose compared to Tasigna® given as a single oral dose in healthy male subjects.
详细描述
The study consists of two parts, the first part is composed as a pilot part and compares the bioavailability of single oral doses of XS003 compared to Tasigna® given as single oral dose in healthy male subjects. The second part is a food-effect part which assesses the food effect of a single oral dose of XS003 in healthy male subjects either fed or fasted. The study will also evaluate safety and tolerability of XS003 as secondary objectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Age 18 to 55 years of age
- •Body mass index (BMI) of 18.0 to 29.0 kg/m2
- •Laboratory parameters in normal range
排除标准
- •Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening.
- •Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
- •History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator.
- •Subject has a QTcF>450 ms based on ECG at screening or a history of additional risk factors for Torsades de Pointe (e.g. hypokalaemia, hypomagnesemia, a family history of long QT syndrome)
研究组 & 干预措施
Tasigna
Marketed capsule
干预措施: Tasigna (Drug)
XS003 Dose-level 3
Capsule formulation
干预措施: XS003 (Drug)
XS003 Dose-level 1
Capsule formulation
干预措施: XS003 (Drug)
XS003 Dose-level 2
Capsule formulation
干预措施: XS003 (Drug)
结局指标
主要结局
Bioavailability of Nilotinib
时间窗: 3 days
Pharmacokinetics measured by Area Under the Curve (AUC)
次要结局
未报告次要终点