The Impact of Genetic Determinants of Fenofibrate's Pharmacogenetics on Lipid Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Pharmacokinetics- serum concentration of fenofibric acid AUC (0-24hrs) for high vs low metabolizers
研究概览
简要总结
The purpose of the study is to learn whether genetics plays a role in predicting response to a commonly used and FDA (Food and Drug Administration) approved medication for lowering triglycerides and cholesterol. The hypothesis: The pharmacogenetics of genes which affect drug metabolism (how the body handles the drug) and drug targets (how the drug acts on the body) influences how a person responds to the lipid lowering medication-fenofibrate.
详细描述
The investigators seek to screen over 200 subjects for select candidate genes to serve as a source of subjects which may participate in a genotype guided investigation as to the predictability of response based on genotype. Response endpoints relate to lipid parameters and other variables of interest to cardiovascular endpoints. Subjects with genotypes of interest would then be enrolled into a short term clinical trial evaluating their response to fenofibrate based on their genetic profile ascertained from the screening phase.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-75 year old
- •Be willing to participate in the study and attend the scheduled clinic exams
- •Consent to taking lipid lowering therapy for 4 weeks and if necessary discontinue lipid lowering agents for a period of 8 weeks
排除标准
- •<18 years of age
- •History of liver, kidney, pancreas, pancreatitis, gall bladder disease or malabsorption (Crohn's disease etc.)
- •Use of insulin or currently taking warfarin
- •Pregnant women or women of childbearing potential not using an acceptable form of contraception
- •History of an allergy or hypersensitivity to fenofibrate
- •Investigational drug use within 30 days of the study
- •A disease that, in the opinion, of the PI, would put the subject at risk during the study
研究组 & 干预措施
1
High drug metabolism genotype All receive fenofibrate
干预措施: fenofibrate (Drug)
2
Low drug metabolism genotype All receive fenofibrate
干预措施: fenofibrate (Drug)
结局指标
主要结局
Pharmacokinetics- serum concentration of fenofibric acid AUC (0-24hrs) for high vs low metabolizers
时间窗: 24 hours
We measured area under the curve (AUC) in mcg\*hr/mL (from time 0 to 24 hrs) at steady state for those of two specific genotypes for our UGT2B7 SNP following steady-state dosing of fenofibrate.
次要结局
未报告次要终点