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FPI: Fenofibrate and Pharmacogenetic Impact in Dyslipidemia

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT00613613
Collaborator
Laval University (Other)
56
Enrollment
1
Location
71
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to learn whether genetics plays a role in predicting response to a commonly used and FDA (Food and Drug Administration) approved medication for lowering triglycerides and cholesterol. The hypothesis: The pharmacogenetics of genes which affect drug metabolism (how the body handles the drug) and drug targets (how the drug acts on the body) influences how a person responds to the lipid lowering medication-fenofibrate.

Condition or Disease Intervention/Treatment Phase

Detailed Description

The investigators seek to screen over 200 subjects for select candidate genes to serve as a source of subjects which may participate in a genotype guided investigation as to the predictability of response based on genotype. Response endpoints relate to lipid parameters and other variables of interest to cardiovascular endpoints. Subjects with genotypes of interest would then be enrolled into a short term clinical trial evaluating their response to fenofibrate based on their genetic profile ascertained from the screening phase.

Study Design

Study Type:
Observational
Actual Enrollment :
56 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Impact of Genetic Determinants of Fenofibrate's Pharmacogenetics on Lipid Response
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
1

High drug metabolism genotype All receive fenofibrate

Drug: fenofibrate
Fenofibrate 145mg tablets once daily for 4 weeks
Other Names:
  • TriCor® 145mg tablets

    		•
    2

    Low drug metabolism genotype All receive fenofibrate

    Drug: fenofibrate
    Fenofibrate 145mg tablets once daily for 4 weeks
    Other Names:
  • TriCor® 145mg tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics- serum concentration of fenofibric acid AUC (0-24hrs) for high vs low metabolizers [24 hours]

      We measured area under the curve (AUC) in mcg*hr/mL (from time 0 to 24 hrs) at steady state for those of two specific genotypes for our UGT2B7 SNP following steady-state dosing of fenofibrate.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 18-75 year old

    • Be willing to participate in the study and attend the scheduled clinic exams

    • Consent to taking lipid lowering therapy for 4 weeks and if necessary discontinue lipid lowering agents for a period of 8 weeks

    Exclusion Criteria:

    • <18 years of age

    • History of liver, kidney, pancreas, pancreatitis, gall bladder disease or malabsorption (Crohn's disease etc.)

    • Use of insulin or currently taking warfarin

    • Pregnant women or women of childbearing potential not using an acceptable form of contraception

    • History of an allergy or hypersensitivity to fenofibrate

    • Investigational drug use within 30 days of the study

    • A disease that, in the opinion, of the PI, would put the subject at risk during the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • University of Minnesota
    • Laval University

    Investigators

    • Principal Investigator: Robert J. Straka, University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00613613
    Other Study ID Numbers:
    • 0708M15441
    • AHA Grant #0755839Z
    First Posted:
    Feb 13, 2008
    Last Update Posted:
    Jan 13, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Dyslipidemias
    Fenofibrate

    Study Results

    No Results Posted as of Jan 13, 2020