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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