NCT00828165已完成1 期
A Safety Study of ARRY-300 in Healthy Subjects
Array Biopharma, now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2009年1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
- 试验地点
- 1
- 主要终点
- Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
研究概览
简要总结
This is a Phase 1 study, involving a 1-day dosing period (up to 3 dosing periods per subject), designed to test the safety of investigational study drug ARRY-300 in healthy subjects. Approximately 12 healthy subjects from the US will be enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female (females must be of non-childbearing potential) between the ages of 18 and 50 years, inclusive.
- •Body mass index (BMI) of 18 kg/m2 to 35 kg/m2; and a total body weight > 50 kg (110 lbs) and < 113 kg (280 lbs).
- •Additional criteria exist.
排除标准
- •Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, dermatologic, or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •A condition possibly affecting drug absorption (e.g., gastrectomy).
- •Women who are pregnant or breastfeeding.
- •A positive test for drugs or alcohol.
- •Use of tobacco- or nicotine-containing products in excess of 5 cigarettes per day, or daily use of pipe, cigar, chewing tobacco or nicotine gum or patches.
- •Treatment with an investigational drug within 30 days prior to first dose of study drug.
- •Use of prescription or nonprescription drugs, vitamins, grapefruit juice, and dietary or herbal supplements within 14 days prior to the first dose of study drug. As exceptions, acetaminophen may be used at doses of ≤ 1 g/day or ibuprofen may be used at doses of ≤ 800 mg/day until 24 hours prior to first dose of study drug.
- •Blood donation of ≥ 1 pint within 30 days prior to first dose of study drug.
- •Evidence of hepatitis B or C, or human immunodeficiency virus (HIV) infection upon serological testing.
- •Additional criteria exist.
研究组 & 干预措施
ARRY-300
Experimental
干预措施: ARRY-300, MEK inhibitor; oral (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
时间窗: Duration of study
Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations.
时间窗: Following a single dose
次要结局
- Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.(Duration of study)
研究者
研究点 (1)
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