LXRA Gene Polymorphisms and Response to Fenofibrate

NCT ID: NCT00644592

Last Updated: 2012-06-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-08-31

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

1-Fenofibrate then Placebo

4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo

Group Type: ACTIVE_COMPARATOR

Fenofibrate capsule daily for 4 weeks

Intervention Type: DRUG

Placebo capsule daily for 4 weeks

Fenofibrate

Intervention Type: DRUG

160 mg/day orally for 4 weeks

2 Placebo then Fenofibrate

4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.

Group Type: ACTIVE_COMPARATOR

Fenofibrate capsule daily for 4 weeks

Intervention Type: DRUG

Placebo capsule daily for 4 weeks

Fenofibrate

Intervention Type: DRUG

160 mg/day orally for 4 weeks

Interventions

Fenofibrate capsule daily for 4 weeks

Placebo capsule daily for 4 weeks

Intervention Type: DRUG

Fenofibrate

160 mg/day orally for 4 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American College of Clinical Pharmacy

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Issam Zineh, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics

Locations

University of Florida College of Pharmacy, Center for Pharmacogenomics

Gainesville, Florida, United States

Countries

United States

Other Identifiers

302-2007

Identifier Type: -

Identifier Source: org_study_id