Identification of Null Allelic Variant of CYP2C8 In A Korean Population

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rosiglitazone; Genetic: CYP2C8 genotype

• Registration Number: NCT01872780
• Lead Sponsor: Inje University

Brief 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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-02
• Study Completion: 2009-03
• Study First Submitted: 2011-12-06
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-05
• Last Update Submitted: 2013-06-05
• Study First Posted: 2013-06-07
• Last Update Posted: 2013-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Healthy volunteer

Exclusion Criteria

• Medical problems in taking probe drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rosiglitazone	CYP2C8 genotype	avandia
genetic polymorphism	CYP2C8 genotype	avandia CYP2C8 genotype
rosiglitazone	Rosiglitazone	avandia
genetic polymorphism	Rosiglitazone	avandia CYP2C8 genotype

Primary Outcome Measures

Name	Time	Method
AUC	12hr	0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h

Secondary Outcome Measures

Name	Time	Method
Cmax	12hr	0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h