Disposition of [14C] ABT-199 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) Following a Single Oral Dose Administration
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Time to Cmax (Tmax) for ABT-199 and [14C]ABT-199
研究概览
简要总结
A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with Non-Hodgkin's Lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject must have relapsed or refractory disease.
- •Subject must have histologically documented diagnosis of non-hodgkin's lymphoma as defined by a B-cell neo-plasm in the World Health Organization (WHO) classification scheme except as noted in exclusion criteria.
- •Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-
- •Subject has adequate bone marrow (independent of growth factor support per local laboratory reference range).
- •Subject has adequate coagulation, renal and hepatic function.
排除标准
- •Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), or small lymphocytic lymphoma (SLL).
- •Subject has undergone an allogeneic stem cell transplant.
- •Subject is receiving combination anti-retroviral therapy for human immunodeficiency virus (HIV) (due to potential drug-drug interactions, as well as the potential for increased risk of opportunistic infections).
- •Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease within 6 months that in the opinion of the Investigator would adversely affect his/her participation in this study.
- •Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
研究组 & 干预措施
[14C]ABT-199
Subjects with relapsed or refractory Non-Hodgkin's Lymphoma
干预措施: [14C]ABT-199 (GDC-0199) (Drug)
结局指标
主要结局
Time to Cmax (Tmax) for ABT-199 and [14C]ABT-199
时间窗: For approximately 9 days following a single oral dose of [14C]ABT-199
Maximum observed plasma concentration (Cmax) of ABT-199 and [14C]ABT-199
时间窗: For approximately 9 days following a single oral dose of [14C]ABT-199
Area Under the Time curve (AUC) for ABT-199 and [14C]ABT-199
时间窗: For approximately 9 days following a single oral dose of [14C]ABT-199
The area under the exposure-time curve from time zero to Day 9 and time zero extrapolated to infinite time for single dose of \[14C\]ABT-199
次要结局
- Percentage of subjects with adverse events(At each visit (daily for approximately the first 9 days))
- Number of subjects with adverse events(At each visit (daily for approximately the first 9 days))