Fenofibrate and Pharmacogenetic Impact in Dyslipidemia

NCT00613613 | Completed FDA Drug

• 2 other identifiers: 0708M15441AHA Grant #0755839Z
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

High drug metabolism genotype All receive fenofibrate

Drug: fenofibrate

2

Low drug metabolism genotype All receive fenofibrate

Drug: fenofibrate

Interventions

fenofibrate DRUG

Fenofibrate 145mg tablets once daily for 4 weeks

Also known as: TriCor® 145mg tablets

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with dyslipidemia

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Minnesota: lead
• Laval University: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Officials

• Robert J. Straka

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (1)