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Trial record 41 of 571 for:    Genetic AND SNP

Identification of Null Allelic Variant of CYP2C8 In A Korean Population

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ClinicalTrials.gov Identifier: NCT01872780
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
Jae-Gook Shin, 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Rosiglitazone Genetic: CYP2C8 genotype Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : August 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : March 2009

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Arm Intervention/treatment
Active Comparator: rosiglitazone
avandia
Drug: Rosiglitazone
single oral administration of 4mg of rosiglitazone
Other Name: Avandia

Genetic: CYP2C8 genotype
CYP2C8*11.
Other Name: avandia

Active Comparator: genetic polymorphism
avandia CYP2C8 genotype
Drug: Rosiglitazone
single oral administration of 4mg of rosiglitazone
Other Name: Avandia

Genetic: CYP2C8 genotype
CYP2C8*11.
Other Name: avandia




Primary Outcome Measures :
  1. AUC [ Time Frame: 12hr ]
    0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h


Secondary Outcome Measures :
  1. Cmax [ Time Frame: 12hr ]
    0h,0.33h,0.66h,1h,1.5h,2h,3h,4h,6h,8h,12h,24h



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer

Exclusion Criteria:

  • Medical problems in taking probe drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872780


Sponsors and Collaborators
Inje University
Investigators
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Principal Investigator: Jae-Gook Shin, MD, PhD Inje University

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Responsible Party: Jae-Gook Shin, Department of Pharmacology and Pharmacogenomics Research Center, Inje University
ClinicalTrials.gov Identifier: NCT01872780     History of Changes
Other Study ID Numbers: 08-101
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

Keywords provided by Jae-Gook Shin, Inje University:
CYP2C8
genetic polymorphism
rosiglitazone
Korean

Additional relevant MeSH terms:
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Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs