NCT00658554已完成1 期
Bioequivalence Study of ARQ 197 Amorphous and Crystalline Polymorphs A and B in Normal Healthy Volunteers
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- To obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.
研究概览
简要总结
This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.
详细描述
This is a bioequivalence study designed to compare three solid states of ARQ 197 in normal healthy volunteers using a randomized crossover design.
The primary objective is to obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must provide written informed consent prior to any study related procedures
- •Subjects must be between the ages of 18 and 65 years
- •Male participants must have been surgically sterilized
- •Female participants must have been surgically sterilized or be post menopausal and must have a negative serum pregnancy test
- •All participants will be phenotypically extensive metabolizers based on their CYP C19 genotype.
排除标准
- •Males who are not surgically sterilized
- •Females of child-bearing potential who are not surgically sterilized
- •Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
- •Any clinically significant abnormality in the screening laboratory tests or ECG
- •Received any investigational drugs within four weeks
- •Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
结局指标
主要结局
To obtain pharmacokinetic data to assess bioequivalence among three solid states of ARQ 197: amorphous, crystalline polymorph A and crystalline polymorph B.
时间窗: May 2008
次要结局
- To monitor safety of the three solid states of ARQ 197.(May 2008)
研究者
研究点 (2)
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