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LXRA Gene Polymorphisms and Response to Fenofibrate

This study has been terminated.
(supply issues with the formulation of fenofibrate that was used.)
Sponsor:
Collaborator:
American College of Clinical Pharmacy
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00644592
First received: March 21, 2008
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Drug: Fenofibrate capsule daily for 4 weeks
Drug: Fenofibrate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: LXRA Gene Polymorphisms and Response to Fenofibrate

Resource links provided by NLM:

Drug Information available for: Fenofibrate
U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Log(ENA-Period 2 End/ENA Period 1 End) [ Time Frame: week 12 to week 4 ] [ Designated as safety issue: No ]

    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



Enrollment: 11
Study Start Date: March 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644592

Locations
United States, Florida
University of Florida College of Pharmacy, Center for Pharmacogenomics
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
American College of Clinical Pharmacy
Investigators
Principal Investigator: Issam Zineh, PharmD University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00644592     History of Changes
Other Study ID Numbers: 302-2007
Study First Received: March 21, 2008
Results First Received: March 12, 2012
Last Updated: May 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Healthy Volunteers

Additional relevant MeSH terms:
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013