LXRA Gene Polymorphisms and Response to Fenofibrate

May 24, 2012 updated by: University of Florida
This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Pharmacy, Center for Pharmacogenomics

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Triglycerides equal to or above 150mg/dL or Low HDL (below 44 mg/dl for men or below 54 mg/dl for women)
  • Must be able to swallow tablets

Exclusion Criteria:

  • Known Coronary Heart Disease, symptomatic carotid artery disease, abdominal aortic aneurysm, diabetes, or Framingham risk score above 20%
  • Pregnancy, malignancy, liver dysfunction, renal dysfunction, active alcohol abuse, history of unexplained muscle pain
  • Current treatment with lipid lowering therapy, estrogens, androgens, progestins, thiazide diuretics, beta-blockers, glucocorticoids (other than inhaled), antihistamines, or chronic anti-inflammatory drugs
  • Current treatment with the following the interacting drugs: ursodeoxycholic acid, ursodiol, cholestyramine, red yeast rice, glyburide, glipizide, warfarin, or cyclosporine

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1-Fenofibrate then Placebo
4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo
Drug: Fenofibrate capsule daily for 4 weeks
Placebo capsule daily for 4 weeks
Drug: Fenofibrate
160 mg/day orally for 4 weeks
Active Comparator: 2 Placebo then Fenofibrate
4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.
Drug: Fenofibrate capsule daily for 4 weeks
Placebo capsule daily for 4 weeks
Drug: Fenofibrate
160 mg/day orally for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Log(ENA-Period 2 End/ENA Period 1 End)
Time Frame: week 12 to week 4

Log of the ratio of Period end ENA-78 Period 2:Period 1. Once the confidence interval is obtained, we take antilogs to obtain a ratio of effects.

Natural logs used
week 12 to week 4

Collaborators and Investigators

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

Sponsor

University of Florida

Collaborators

American College of Clinical Pharmacy

Investigators

  • Principal Investigator: Issam Zineh, PharmD, University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics

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

March 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 21, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Estimate)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 24, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 302-2007

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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