Identification of Null Allelic Variant of CYP2C8 In A Korean Population

Inje University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Genetic: CYP2C8 genotype; Drug: Rosiglitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT01872780

08-101

Details and patient eligibility

About

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 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.

Enrollment: 11 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteer

Exclusion criteria

• Medical problems in taking probe drug

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

rosiglitazone

Active Comparator group

Description:

avandia

Treatment:

Drug: Rosiglitazone

Genetic: CYP2C8 genotype

genetic polymorphism

Active Comparator group

Description:

avandia CYP2C8 genotype

Treatment:

Drug: Rosiglitazone

Genetic: CYP2C8 genotype