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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

Page last updated: August 20, 2015

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