Identification of Null Allelic Variant of CYP2C8 In A Korean Population
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: February 2009
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.
Interventions
- Drug: Rosiglitazone
- single oral administration of 4mg of rosiglitazone
- Genetic: CYP2C8 genotype
- CYP2C8*11.
Arms, Groups and Cohorts
- Active Comparator: rosiglitazone
- avandia
- Active Comparator: genetic polymorphism
- avandia CYP2C8 genotype
Clinical Trial Outcome Measures
Primary Measures
- AUC
- Time Frame: 12hr
- 0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h
Secondary Measures
- Cmax
- Time Frame: 12hr
- 0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h
Participating in This Clinical Trial
Inclusion Criteria
- Healthy volunteer Exclusion Criteria:
- Medical problems in taking probe drug
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Inje University
- Provider of Information About this Clinical Study
- Principal Investigator: Jae-Gook Shin, Department of Pharmacology and Pharmacogenomics Research Center – Inje University
- Overall Official(s)
- Jae-Gook Shin, MD, PhD, Principal Investigator, Inje University
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