A Phase I, Single-center, Randomized, Open-label, Crossover Study to Compare the White (Current Phase II) and Blue (Planned Phase III) Capsule Formulations of AZD6244 Hyd-Sulfate in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- AUC for AZD6244 administered as a single dose of white (current Phase II) capsule formulation
研究概览
简要总结
Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.
详细描述
A Phase I, Single-center, Randomized, Open-label, Crossover Study to Compare the White (Current Phase II) and Blue (Planned Phase III) Capsule Formulations of AZD6244 Hyd-Sulfate in Healthy Male Subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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 male volunteers aged 18 to 55 BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive Calculated creatinine clearance (CRCL) greater than 50 mL/min usin gthe Cockcroft-Gault formula
排除标准
- •History or presence of gastrointestinal, hepatic, or renal disease or any other condition know to interfere with absorption, distribution, metabolism, or exertion of drugs.
- •Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
- •Any clinically important abnormalities in rhythm, conduction, or morphology of the resting dECG and any clinically important abnormalities in the 12-lead dECG that suggest a cardiac, metabolic or other noncardiac condition.
- •Current or past history of central serous retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma Known or suspected history of drug abuse, current smokes or those who have smoked or used nicotine-containing products within the previous 3 months
研究组 & 干预措施
AZD6244 white capsule
75mg AZD6244 white (current Phase II) capsule
干预措施: AZD6244 Dosing Period 1 (Drug)
AZD6244 white capsule
75mg AZD6244 white (current Phase II) capsule
干预措施: AZD6244 Dosing Period 2 (Drug)
AZD6244 white capsule
75mg AZD6244 white (current Phase II) capsule
干预措施: AZD6244 Dosing Period 3 (Drug)
AZD6244 blue capsule
75mg AZD6244 blue (planned Phase III) capsule
干预措施: AZD6244 Dosing Period 1 (Drug)
AZD6244 blue capsule
75mg AZD6244 blue (planned Phase III) capsule
干预措施: AZD6244 Dosing Period 2 (Drug)
AZD6244 blue capsule
75mg AZD6244 blue (planned Phase III) capsule
干预措施: AZD6244 Dosing Period 3 (Drug)
AZD6244 blue capsule
75mg AZD6244 blue (planned Phase III) capsule
干预措施: AZD6244 Dosing Period 4 (Drug)
AZD6244 solution
35mg AZD6244 oral solution
干预措施: AZD6244 Dosing Period 1 (Drug)
AZD6244 solution
35mg AZD6244 oral solution
干预措施: AZD6244 Dosing Period 2 (Drug)
AZD6244 solution
35mg AZD6244 oral solution
干预措施: AZD6244 Dosing Period 3 (Drug)
结局指标
主要结局
AUC for AZD6244 administered as a single dose of white (current Phase II) capsule formulation
时间窗: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Cmax for AZD6244 administered as a ingle dose of white (current Phase II) capsule formulation
时间窗: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
AUC for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation
时间窗: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
Cmax for AZD6244 administered as a single dose of blue (planned Phase III) capsule formulation
时间窗: Measured at appropriate time-points until end of treatment peiod, approximately 24 days
次要结局
- Frequency and severity of adverse events(Measured throughout the study and for a7 days after the last dose, approximately 29 days)
- AUC for AZD6244 administered as a single dose of oral solution formulation(Measured at appropriate time-points until end of treatment peiod, approximately 24 days)
- Cmax for AZD6244 administered as a single dose of oral solution formulation(Measured at appropriate time-points until end of treatment peiod, approximately 24 days)