Identification of Null Allelic Variant of CYP2C8 In A Korean Population

June 5, 2013 updated by: Jae-Gook Shin, Inje University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:

  • Medical problems in taking probe drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: rosiglitazone
avandia
Drug: Rosiglitazone
single oral administration of 4mg of rosiglitazone
Other Names:
  • Avandia
Genetic: CYP2C8 genotype
CYP2C8*11.
Other Names:
  • avandia
Active Comparator: genetic polymorphism
avandia CYP2C8 genotype
Drug: Rosiglitazone
single oral administration of 4mg of rosiglitazone
Other Names:
  • Avandia
Genetic: CYP2C8 genotype
CYP2C8*11.
Other Names:
  • avandia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: 12hr
0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h
12hr

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 12hr
0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h
12hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Principal Investigator: Jae-Gook Shin, MD, PhD, Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

December 6, 2011

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

June 7, 2013

Last Update Submitted That Met QC Criteria

June 5, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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