NCT01121133已完成1 期
A Phase I Study to Assess the Effect of a CYP3A Inducer (Rifampin) on the Pharmacokinetics of ABT-263 (Navitoclax)
AbbVie0 个研究点目标入组 12 人开始时间: 2010年5月最近更新:
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
- 入组人数
- 12
- 主要终点
- To determine the effect of rifampin on the pharmacokinetics of navitoclax.
研究概览
简要总结
This is an open-label, single or multiple center study to determine the interaction of rifampin with navitoclax (ABT-263) in approximately 12 subjects with cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A (navitoclax and rifampin)
Experimental
干预措施: navitoclax (Drug)
Arm A (navitoclax and rifampin)
Experimental
干预措施: Rifampin (Drug)
结局指标
主要结局
To determine the effect of rifampin on the pharmacokinetics of navitoclax.
时间窗: Weekly
次要结局
- To determine the safety of navitoclax when administered alone and in combination with rifampin in these patients.(Daily)
研究者
相似试验
已完成
1 期
A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive TumorsCancerNCT01954043GlaxoSmithKline23
已完成
1 期
Drug-Interaction Study to Evaluate the Effect of Rifampin, a Potent CYP3A4 Inducer, on the Systemic Exposure of Pacritinib in Healthy SubjectsHealthy SubjectsNCT02807116CTI BioPharma18
撤回
1 期
A Study to Assess the Effect of Rifampin on the Metabolism of ABT-199Non-Hodgkin's LymphomaNCT01969682AbbVie
已完成
1 期
Phase 1 Study in Healthy Subjects to Evaluate the Effect of Rifampin on the Pharmacokinetics of IPI-145HealthyNCT01947777SecuraBio14
已完成
1 期
A Study of Baricitinib and Rifampicin in Healthy ParticipantsHealthy VolunteersNCT01910311Eli Lilly and Company18
