NCT01349725已完成1 期
A Safety Study of ARRY-502 in Healthy Subjects
Array Biopharma, now a wholly owned subsidiary of Pfizer0 个研究点目标入组 32 人开始时间: 2011年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 主要终点
- Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
研究概览
简要总结
This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects from the United States will be enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 between the ages of 18 and 50 years.
- •Females must be of nonchildbearing potential.
- •Body mass index (BMI) of 18 to 32 and a total body weight > 50 kg (110 lbs) and < 114 kg (250 lbs).
- •Additional criteria exist.
排除标准
- •Evidence or history of clinically significant disease (excepting allergic rhinitis).
- •Evidence of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- •Gastrointestinal surgery that may interfere with motility or absorption.
- •Serious illness requiring hospitalization within the previous 6 months.
- •A positive test for drugs or alcohol.
- •Recent use of tobacco- or nicotine-containing products. Use of any medications, grapefruit or supplements within the previous 14 days.
- •Use of corticosteroids within the previous 28 days.
- •Recent history of blood, plasma or platelet donation.
- •Treatment with a small-molecule investigational drug within the previous 30 days or any biologic therapy within the previous 6 months.
- •Prior exposure to investigational study drug ARRY-
- •Additional criteria exist.
研究组 & 干预措施
ARRY-502
Experimental
干预措施: ARRY-502 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
时间窗: 2 weeks
Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests, electrocardiograms and vital signs.
时间窗: 3 weeks
次要结局
- Characterize the pharmacodynamics of the study drug as determined by laboratory assays.(2 weeks)
研究者
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