NCT01872780

Identification of Null Allelic Variant of CYP2C8 In A Korean Population

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Inje University · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rosiglitazone	single oral administration of 4mg of rosiglitazone
GENETIC	CYP2C8 genotype	CYP2C8\*11.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2013-06-07
• Last updated: 2013-06-07