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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Inje University
- Enrollment
- 11
- Primary Endpoint
- AUC
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteer
Exclusion Criteria
- •Medical problems in taking probe drug
Arms & Interventions
genetic polymorphism
avandia CYP2C8 genotype
Intervention: CYP2C8 genotype (Genetic)
rosiglitazone
avandia
Intervention: Rosiglitazone (Drug)
rosiglitazone
avandia
Intervention: CYP2C8 genotype (Genetic)
genetic polymorphism
avandia CYP2C8 genotype
Intervention: Rosiglitazone (Drug)
Outcomes
Primary Outcomes
AUC
Time Frame: 12hr
0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h
Secondary Outcomes
- Cmax(12hr)
Investigators
Jae-Gook Shin
Department of Pharmacology and Pharmacogenomics Research Center
Inje University