An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2
研究概览
简要总结
The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18-55 and healthy
排除标准
- •severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse
- •pregnant or wanting to become pregnant
研究组 & 干预措施
Part1; controlled release formulation 4; 250 mg
one 250 mg controlled release tablet, once in the morning, in fasted state
干预措施: CE-224,535 (Drug)
Part1; controlled release formulation 4; 500 mg
2x250 mg, once in the morning, in fasted state
干预措施: CE-224,535 (Drug)
Part 1; controlled release formula 4; 1000 mg
4x250 mg tabs, once in the morning, in fasted state
干预措施: CE-224,535 (Drug)
Part 1; controlled release formulation 4; 500 mg FED
2x250 mg, once in the morning , in fed state
干预措施: CE-224,535 (Drug)
Part 2; IR formulation 500mg
4x125 mg tab of current formulation , once in the morning in the fasted state. This arm will occur as Part 2, only as needed, pending results of Part 1
干预措施: CE-224,535 (Drug)
Part 2; IR formulation, 500 mg FED
4x125 mg once in the morning in the fed state. This arm will occur as part of Part 2,only as needed, pending results of Part 1.
干预措施: CE-224,535 (Drug)
Part 2; controlled release formulation 5;500 mg, FASTED
2x250 controlled release formulation 5 tabs once in the morning in the fasted state. This arm will only occur as part of Part 2, pending results of Part 1.
干预措施: CE 224,535 (Drug)
Part 2; controlled release formulation 5;500 mg, FED
2x250 mg controlled release formulation 5 tabs once in the morning in the fed state. This arm will only occur as part of Part 2 pending results of Part 1
干预措施: CE 224,535 (Drug)
结局指标
主要结局
pharmacokinetic parameters: Tmax, Cmax, AUClast, AUC(0-00), C24, t1/2
时间窗: 48 hrs
次要结局
- safety parameters including: renal and liver function, blood counts, electrolytes, ECG, and pregnancy testing(48 hrs)