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Completed

NCT Number: NCT01872780

Identification of Null Allelic Variant of CYP2C8 In A Korean Population

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.

Completed

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteer

Exclusion criteria

  • Medical problems in taking probe drug

Treatment and study plan

rosiglitazone

Drug

single oral administration of 4mg of rosiglitazone

Other names: Avandia

CYP2C8 genotype

Genetic

CYP2C8*11.

Other names: avandia

Primary outcomes

  1. AUC

    Time frame: 12hr

    0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h

Secondary outcomes

  1. Cmax

    Time frame: 12hr

    0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h

Sponsors and collaborators

Lead sponsor

Inje University

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 7, 2013
Registry last updated
Jun 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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