A Phase 1, Cross-Over, Single-Dose, Open-Label Study to Estimate the Relative Bioavailability of a Modified-Release Formulation of PF-05180999 Under Fed and Fasted Conditions in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to assess the bioavailability, safety, and tolerability of a modified-release formulation of PF-05180999 relative to an immediate-release formulation in healthy adult subjects. Two doses of the modified-release formulation and one dose of the immediate-release formulation will be evaluated under fasted conditions. One dose of the modified-release formulation will also be evaluated in the presence of food.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female of non-childbearing potential
排除标准
- •Evidence of clinically-significant medical illness, history of seizures, any condition possibly affecting drug absorption
研究组 & 干预措施
PF-05180999 Immediate-Release
干预措施: PF-05180999 (Drug)
PF-05180999 Modified-Release 1
干预措施: PF-05180999 (Drug)
PF-05180999 Modified-Release 2
干预措施: PF-05180999 (Drug)
PF-05180999 Modified-Release 1 With Food
干预措施: PF-05180999 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Time to Reach Maximum Observed Plasma Concentration (Tmax)
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Plasma Decay Half-Life (t1/2)
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
时间窗: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
次要结局
未报告次要终点