NCT00651638已完成1 期
A Study of ARQ 197 in Healthy Volunteers to Assess the Pharmacokinetic (PK) Profile in Extensive and Poor Metabolizers as Defined by Cytochrome P450 2C19 (CYP 2C19) Genotype
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 17 人开始时间: 2008年3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
- 17
- 试验地点
- 2
- 主要终点
- To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype
研究概览
简要总结
To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype
详细描述
This is a pharmacokinetic study designed to compare the metabolism of ARQ 197 in normal healthy volunteers who are extensive metabolizers (EM) or poor metabolizers (PM) as defined by CYP 2C19 genotype. This is an open-label, single-dose, parallel group design in which healthy volunteer subjects will receive a single dose of ARQ 197
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 old
- •Male participants must be surgically sterilized
- •Female participants must be surgically sterilized or post menopausal and must have a negative serum pregnancy test. Post Menopausal is defined as at least one year without menses.
- •Subject must, in the opinion of the Investigator, be willing and able to complete the study procedures
排除标准
- •Subject must provide written informed consent prior to any study related procedures
- •Subjects must be between the ages of 18 and 65 years old
- •Male participants must be surgically sterilized
- •Female participants must be surgically sterilized or post menopausal and must have a negative serum pregnancy test. Post Menopausal is defined as at least one year without menses.
- •Subject must, in the opinion of the Investigator, be willing and able to complete the study procedures
结局指标
主要结局
To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as defined by CYP 2C19 genotype
时间窗: May 2008
次要结局
- To assess the effect of other CYP genotypes on the safety profile and PK profile of ARQ 197(May 2008)
研究者
研究点 (2)
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