NCT01164033已完成1 期
An Open-Label, Randomized 3-Way Crossover, Study to Examine the Food-Effect on Pharmacokinetics of the Current Formulation and Relative Bioavailability of Two New Formulations for RO5045337 in Patients With Solid Tumors Including Lymphoma
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
- 76
- 主要终点
- Examination of potential food-effect on pharmacokinetics of RO5045337
研究概览
简要总结
This open-label, randomized, cross-over study will evaluate the effect of food on the pharmacokinetics of single oral doses of RO5045337 in patients with solid tumors. The anticipated time on study treatment is 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Adult patients, >/=18 years of age
- •Histologically confirmed solid tumor
- •Life expectancy of >/=12 weeks
- •ECOG performance status of 0 or 1
- •Adequate bone marrow, renal and hepatic function
排除标准
- •Patients receiving any other investigational agent or therapy administered with the intention to treat their malignancy within 28 days prior to study start
- •Patients with pre-existing gastro-intestinal disorder
- •Patients with uncontrolled intercurrent illness
研究组 & 干预措施
A
Active Comparator
干预措施: RO5045337 (Drug)
B
Experimental
干预措施: RO5045337 (Drug)
C
Experimental
干预措施: RO5045337 (Drug)
D
Experimental
干预措施: RO5045337 (Drug)
结局指标
主要结局
Examination of potential food-effect on pharmacokinetics of RO5045337
时间窗: 3 weeks
Evaluation of relative bioavailability of RO5045337
时间窗: 3 weeks
次要结局
- Evaluation of safety and tolerability of RO5045337(3 weeks)
- Evaluation of pharmacodynamics and biomarkers(3 weeks)
研究者
相似试验
已完成
1 期
A Study to Explore the Effect of Food Before a Single Dose of SitravatinibHealthy AdultsNCT04800614Mirati Therapeutics Inc.36
已完成
1 期
A Study of the Effect of Food on the Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese VolunteersSchizophreniaNCT00892320Johnson & Johnson Pharmaceutical Research & Development, L.L.C.20
已完成
3 期
Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male SubjectsClinical PharmacologyNCT02276274Takeda12
已完成
1 期
A Clinical Trial to Evaluate the Effect of Food on PK and PD of Vicagrel Capsules in Healthy Adult SubjectsAcute Coronary SyndromeNCT04919551Jiangsu vcare pharmaceutical technology co., LTD24
已完成
1 期
Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With RitonavirHCV InfectionNCT00909311Abbott8