The Effect of CYP2C8 E274Q, a Novel 23452 G>T SNP, on the Disposition of Rosiglitazone in Healthy Subjects: The Genetic Polymorphisms of CYP2C8 in a Korean Population
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- AUC
研究概览
简要总结
The genotype profile of CYP2C8 was analyzed in a Korean population. Frequency in multi-ethnic population and in vivo functionality of novel null allelic CYP2C8 variant were evaluated.
详细描述
Whole blood samples from 50 unrelated Korean subjects were genotyped for 3kb of 5' upstream region, all exon-intron boundaries, exons, and UTR regions of CYP2C8 gene by direct sequencing. Genotyping of CYP2C8 has been addressed only for null allelic variant, CYP2C8*11 using pyrosequencing in the 447 Koreans, 93 African-Americans, 100 Caucasians, 348 Chineses and 100 Vietnameses. Then, in-vivo single PK study of CYP2C8 probe, rosiglitazone(4mg), was conducted in 7 healthy subjects with CYP2C8*1/*1 and 2 with CY2C8*1/*11.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer
排除标准
- •Medical problems in taking probe drug
研究组 & 干预措施
genetic polymorphism
avandia CYP2C8 genotype
干预措施: CYP2C8 genotype (Genetic)
rosiglitazone
avandia
干预措施: Rosiglitazone (Drug)
rosiglitazone
avandia
干预措施: CYP2C8 genotype (Genetic)
genetic polymorphism
avandia CYP2C8 genotype
干预措施: Rosiglitazone (Drug)
结局指标
主要结局
AUC
时间窗: 12hr
0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h
次要结局
- Cmax(12hr)
研究者
Jae-Gook Shin
Department of Pharmacology and Pharmacogenomics Research Center
Inje University