NCT01969682撤回1 期
A Phase 1 Study to Assess the Effect of Rifampin on the Pharmacokinetics of ABT-199
AbbVie1 个研究点 分布在 1 个国家开始时间: 2014年4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
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Determination of maximum observed plasma concentration (Cmax), time to Cmax (peak time, Tmax), terminal phase elimination rate constant (beta), terminal phase elimination half-life (t1/2), & area under the plasma concentration-time curve (AUC) of ABT-199
研究概览
简要总结
This is an open-label multicenter, study to assess the pharmacokinetic interaction of rifampin with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's lymphoma.
详细描述
This is a Phase 1 study designed to assess how the body processes the study drug ABT-199 when taken alone and in combination with rifampin and to assess the safety of ABT-199 in combination with rifampin. Subjects may enroll in a separate extension study to continue receiving ABT-199 after completion of this study.
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 non-Hodgkin's lymphoma.
- •Subject must have histologically documented diagnosis of non-Hodgkin's lymphoma as defined by a B-cell neoplasm in the World Health Organization (WHO) classification scheme except as noted in the exclusion criteria.
- •Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to
- •Subject must have adequate bone marrow (independent of growth factor support per local laboratory reference range), coagulation, renal and hepatic function:
- •Absolute Neutrophil Count (ANC) greater than or equal to 1000/µL (without growth factor support unless neutropenia is clearly due to underlying disease);
- •Platelets greater than or equal to 75,000/mm3 (unless thrombocytopenia is clearly due to disease-related immune thrombocytopenia or to underlying disease; entry platelet count must be independent of transfusion within 14 days of Screening);
- •Hemoglobin greater than or equal to 9.0 g/dL (unless anemia is clearly due to underlying disease; entry hemoglobin must be independent of transfusion within 14 days of Screening);
- •If cytopenias are present, no evidence of myelodysplastic syndrome or hypoplastic bone marrow;
- •Subject must have activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 × the upper normal limit (ULN);
- •Calculated creatinine clearance greater than or equal to 50 mL/min using a 24-hour urine collection for creatinine clearance or per the Cockcroft-Gault equation;
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3.0 × ULN of institution's normal range;
- •Bilirubin less than or equal to 1.5 × ULN. Subjects with Gilbert's Syndrome may have a bilirubin greater than 1.5 × ULN per discussion with the AbbVie medical monitor.
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), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL).
- •Subject is receiving combination anti-retroviral therapy for HIV (due to potential drug-drug interactions between anti-retroviral medications and ABT-199, as well as anticipated ABT-199 mechanism based lymphopenia that may potentially increase the risk of opportunistic infections).
- •Subject has hypersensitivity to any of the rifamycins.
- •Subject has a cardiovascular disability status of New York Heart Association Class greater than or equal to
- •Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea or anginal pain.
- •Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease within the past 6 months that in the opinion of the investigator would adversely affect his/her participating in this study.
- •Subject has malabsorption syndrome or other condition which precludes enteral route of administration (e.g., prior surgical resection).
- •Subject has undergone an allogeneic stem cell transplant.
研究组 & 干预措施
Arm A (ABT-199 and rifampin)
Experimental
干预措施: ABT-199 (Drug)
Arm A (ABT-199 and rifampin)
Experimental
干预措施: Rifampin (Drug)
结局指标
主要结局
Determination of maximum observed plasma concentration (Cmax), time to Cmax (peak time, Tmax), terminal phase elimination rate constant (beta), terminal phase elimination half-life (t1/2), & area under the plasma concentration-time curve (AUC) of ABT-199
时间窗: Measured pre-dose and up to 96 hours post-dose ABT-199
Blood samples for pharmacokinetic (PK) analysis of ABT-199 will be collected at designated timepoints to assess the PK parameters for ABT-199 alone relative to ABT-199 with rifampin
次要结局
- Number of subjects with adverse events(Measured up to 30 days after the last dose of study drug)
- Percentage of subjects with adverse events(Measured up to 30 days after the last dose of study drug)
- Change in cardiac assessment findings(Measured from Day 1 up to Day 19)
- Change in physical exam finding, including vital signs(Measured from Day 1 up to 30 days after the last dose of study drug)
- Change in clinical laboratory test results(Measured from Day 1 up to 30 days after the last dose of study drug)
研究者
研究点 (1)
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