NCT00919204已完成1 期
An Open Label Phase 1 Study To Evaluate The Pharmacokinetics Of AG-013736 In Healthy Chinese Volunteers
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
- Pfizer
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Plasma Pharmacokinetics of AG-013736 in Chinese Healthy Volunteers
研究概览
简要总结
As part of the global clinical development program for AG-013736, studies are ongoing (and planned) in cancer patients in China. An assessment of AG-013736 pharmacokinetics in Chinese subjects, as required by the Chinese Health Authorities, is therefore warranted.
In the current study the single dose pharmacokinetics of AG-013736 will be characterized at 3 doses (5 mg, 7 mg and 10 mg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female (of nonchildbearing potential) Chinese (individuals currently residing in mainland China who were born in China and have both parents of Chinese descent) subjects between the ages of 18 and 45 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.)
- •Body Mass Index (BMI) of 19 to 24 kg/m2; and a total body weight >50 kg (110 lbs). A BMI lower limit of 18.5 kg/m2 may be rounded up to 19.0 kg/m2; a BMI upper limit of 24.5 kg/m2 may be rounded down to 24.0 kg/m2 and will be acceptable for inclusion.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •Drug dependency, a positive urine drug screen, or alcohol dependency.
- •History of regular alcohol consumption exceeding 28 or more units per week. (One unit=285 mL of beer or 25 mL of spirits or 125 mL of wine).
- •Use of tobacco- or nicotine-containing products (or a positive urine cotinine test).
- •Treatment with an investigational drug within 3 months (or as determined by local regulations) or 5 half-lives preceding the first dose of study medication.
研究组 & 干预措施
Cohort 1
Experimental
干预措施: AG-013736 (axitinib) (Drug)
结局指标
主要结局
Plasma Pharmacokinetics of AG-013736 in Chinese Healthy Volunteers
时间窗: 3 months
次要结局
- Safety of AG-013736 in Chinese Healthy Volunteers(3 months)
研究者
研究点 (1)
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