NCT01381341已完成1 期
A Phase 1 Pharmacokinetic Study To Compare the Relative Bioavailability of Two Clinical Formulations of Linifanib in Subjects With Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- To determine the pharmacokinetic profile of linifanib in subjects with advanced or metastatic solid tumors.
研究概览
简要总结
A pharmacokinetic study to compare 2 clinical formulations of linifanib.
详细描述
This study is designed to evaluate the bioavailability of linifanib from 2 formulations. Subjects may enroll in a separate extension study to continue receiving linifanib after completion of this study.
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 —（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
linifanib
Experimental
干预措施: linifanib (Drug)
结局指标
主要结局
To determine the pharmacokinetic profile of linifanib in subjects with advanced or metastatic solid tumors.
时间窗: At various time points from Day 1 through Day 5 of Periods 1 and 2
Blood samples for the pharmacokinetics (PK) of linifanib will be collected at designated time points and assayed.
次要结局
- Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety.(Throughout the study)
- Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety.(Physical exam at Screening, Day 1 of Periods 1 and 2 and Day 5, Period 2/Final Visit and 30 day safety follow-up; Vital Signs (blood pressure, heart rate, body temperature) will be done at all visits.)
- Safety: Clinical Lab Tests will be performed for each participant as a safety measure.(Screening, Day 1, Periods 1 and 2, Day 5, Period2/Final Visit and 30 day safety follow-up.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Pharmacokinetics in End Stage Renal Disease PatientsHealthy VolunteersRenal FailureNCT04792333Quantum Genomics SA28
终止
1 期
A Study Evaluating the Bioavailability of Two Formulations of Linifanib and Food Effect on Pharmacokinetics of Linifanib in Subjects With Advanced or Metastatic Solid TumorsAdvanced or Metastatic Solid TumorsNCT01506934Abbott14
已完成
1 期
A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881Healthy VolunteersNCT04128787Agios Pharmaceuticals, Inc.36
已完成
1 期
The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD, Safety and ImmunogenicityHealthy VolunteersNCT05897008Taizhou Mabtech Pharmaceutical Co.,Ltd114
已完成
1 期
A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate TabletGastric UlcerNCT02759224Boryung Pharmaceutical Co., Ltd34