LXRA Gene Polymorphisms and Response to Fenofibrate

Healthy Clinical Trial

Official title:

LXRA Gene Polymorphisms and Response to Fenofibrate

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00644592
• Other study ID #: 302-2007
• Status: Terminated
• Phase: N/A
• First received: March 21, 2008
• Last updated: May 24, 2012
• Start date: March 2008
• Est. completion date: August 2009

Study information

• Verified date: May 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Fenofibrate capsule daily for 4 weeks
Placebo capsule daily for 4 weeks
• Fenofibrate
160 mg/day orally for 4 weeks

Locations

Country	Name	City	State
United States	University of Florida College of Pharmacy, Center for Pharmacogenomics	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	American College of Clinical Pharmacy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Log(ENA-Period 2 End/ENA Period 1 End)	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	No