Identification of Null Allelic Variant of CYP2C8 In A Korean Population
Information source: Inje University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Rosiglitazone (Drug); CYP2C8 genotype (Genetic)
Phase: Phase 1
Status: Completed
Sponsored by: Inje University Official(s) and/or principal investigator(s): Jae-Gook Shin, MD, PhD, Principal Investigator, Affiliation: Inje University
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.
Clinical Details
Official title: 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 design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: AUC
Secondary outcome: Cmax
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy volunteer
Exclusion Criteria:
- Medical problems in taking probe drug
Locations and Contacts
Additional Information
Starting date: August 2008
Last updated: June 5, 2013
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