NCT01199224已完成1 期
A Phase 1, Single-Dose, Randomized, Group Sequential Cross-Over Study Evaluating the Bioavailability and Food Effect of Three Formulations of Veliparib on Pharmacokinetics in Subjects With Solid Tumors
AbbVie0 个研究点目标入组 27 人开始时间: 2010年6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
- 27
- 主要终点
- Assess the oral bioavailability of veliparib
研究概览
简要总结
Compare the bioavailability of three veliparib formulations in subjects with solid tumors.
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
- •Subjects with cytologically/histologically confirmed solid tumors that are either relapsed or refractory to standard therapy or there is no known effective therapy.
- •In the opinion of the Investigator, life expectancy is 12 weeks or greater.
- •Subjects with known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of central nervous system (CNS) disease progression as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI) within 21 days prior to the first dose of study drug.
- •Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to
- •Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.
排除标准
- •The subject is unable to swallow capsules or has nausea or vomiting.
- •Female subject is pregnant or breast-feeding.
- •Subject has a history of or an active medical condition(s) that affects absorption or motility (e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome).
- •History of gastric surgery, vagotomy, bowel resection (except for left hemicolectomy) or any surgical procedure that might interfere with gastrointestinal motility, potentiometric hydrogen ion concentration (pH) or absorption.
- •Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- •Known seizure disorder that is uncontrolled over the past month
- •Active uncontrolled infection
- •Unstable angina pectoris or cardiac arrhythmia
- •Psychiatric illness/social situation that would limit compliance with study requirements
研究组 & 干预措施
Arm A
Experimental
干预措施: veliparib (Drug)
Arm B
Experimental
干预措施: veliparib (Drug)
Arm C
Experimental
干预措施: veliparib (Drug)
Arm D
Experimental
干预措施: veliparib (Drug)
结局指标
主要结局
Assess the oral bioavailability of veliparib
时间窗: Up to 4 weeks.
Assess the relative bioavailability of Formulation A, Formulation B and Formulation C with or without food measured using area under the plasma concentration-time curve (AUC), the maximum observed plasma concentration (Cmax), and time to Cmax (Tmax).
次要结局
- To evaluate the safety and tolerability of veliparib in patients with solid tumors(Up to 4 weeks)
研究者
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