NCT00363194已完成1 期
An Open-Label, Two-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Single Doses of Pazopanib in Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- PK parameters: Cmax, tmax, and AUC
研究概览
简要总结
This is two-part study (Part I/Part II). Part I is designed to determine the effect of a low and high fat meal on the pharmacokinetics of single dose pazopanib (GW572016). Part II is designed to allow patients continued access to study drug in a multiple dosing regimen. Patients who are receiving clinical benefit on that regimen will go into the long term rollover study VEG105430 provided they are stable for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lead-In cohort
Experimental
In Part 1 of Lead-In cohort, subjects will be dosed with a single dose of pazopanib with a high-fat breakfast to establish safety and tolerability.
干预措施: Pazopanib (GW786034) (Drug)
结局指标
主要结局
PK parameters: Cmax, tmax, and AUC
时间窗: Day 1 and Day 15
次要结局
- Safety and tolerability parameters include evaluation of adverse events (AEs), and changes in clinical laboratory, and vital signs assessments under fed and fasted conditions(14 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Food-drug Interaction Study of SY-004 in Healthy SubjectsType 2 DiabetesNCT04907006Suzhou Yabao Pharmaceutical R&D Co., Ltd.24
已完成
1 期
Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy AdultsHealthy VolunteersNCT03397329Agios Pharmaceuticals, Inc.26
已完成
1 期
Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) FormulationCancerNCT01647659GlaxoSmithKline18
已完成
1 期
Effect of Food on the Pharmacokinetics of ORIC-114Food Effect in Healthy ParticipantsNCT06012721ORIC Pharmaceuticals32
已完成
1 期
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy SubjectsPharmacokineticsNCT04092725Scynexis, Inc.36