Role of CYP2B6 Polymorphisms in Ketamine Metabolism and Clearance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype.
研究概览
简要总结
This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes ketamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •18-50 yr old
- •CYP2B6*1/*1, CYP2B6*1/*6 or CYP2B6*6/*6 genotype (see table) (Note: subjects of other rare genotype but with one or more 516G>T, 785A>G, 983T>C or 1459C>T polymorphism may be enrolled at PI's discretion)
- •Good general health with no remarkable medical conditions
- •Provided informed consent
排除标准
- •Known history of liver or kidney disease
- •Use of prescription or non prescription medications, herbals, foods or chemicals known to be metabolized by or affecting CYP2B6
- •Females who are pregnant or nursing
- •Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
- •Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential)
研究组 & 干预措施
Ketamine arm- *1/*1
1.*1/*1- oral racemic ketamine 0.4 mg/kg
干预措施: ketamine (Drug)
Ketamine arm - *1/*6
- *1/*6- oral racemic ketamine 0.4 mg/kg
干预措施: ketamine (Drug)
Ketamine arm - *6/*6
- *6/*6- oral racemic ketamine 0.4 mg/kg
干预措施: ketamine (Drug)
结局指标
主要结局
The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype.
时间窗: up to 24 hours
Ketamine metabolism, measured as the plasma norketamine/ketamine AUC ratio in CYP2B6\*6 carriers (CYP2B6\*6 hetero or homozygotes) compared to the wild-type CYP2B6\*1/\*1 genotype Ketamine, norketamine, and dehydronorketamine concentrations in plasma and urine were determined by enantioselective HPLC tandem mass spectrometry, using solid phase extraction, based on a modification of a published method.
次要结局
未报告次要终点