Fenofibrate and Pharmacogenetic Impact in Dyslipidemia (FPI)

The Impact of Genetic Determinants of Fenofibrate's Pharmacogenetics on Lipid Response

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: fenofibrate

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 Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults with dyslipidemia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics- serum concentration of fenofibric acid AUC (0-24hrs) for high vs low metabolizers	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.	24 hours

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Laval University
• Investigators: Principal Investigator: Robert J. Straka, University of Minnesota

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 31, 2008
• First Submitted That Met QC Criteria: February 12, 2008
• First Posted (Estimate): February 13, 2008

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: 0708M15441; AHA Grant #0755839Z (Other Identifier: University of Minnesota)

Drug and device information, study documents

• 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