TerminatedNCT00644592Updated Jun 1, 2012Results posted

LXRA Gene Polymorphisms and Response to Fenofibrate

An interventional study of Fenofibrate capsule daily for 4 weeks and Fenofibrate in Healthy, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-01.

Sponsored by University of Florida · Not applicable, Interventional, and Basic science

Why this study was terminated

supply issues with the formulation of fenofibrate that was used.

Phase: Not applicable
Study type: Interventional
Enrollment: 11
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 studied

Healthy

Keywords

Healthy Volunteers

In context

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 11 participants (actual)

Study arms

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 · Drug: Fenofibrate
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 · Drug: Fenofibrate

Interventions

DrugFenofibrate capsule daily for 4 weeks
Placebo capsule daily for 4 weeks
DrugFenofibrate
160 mg/day orally for 4 weeks

What researchers measure

Primary outcomes

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
Time frame: week 12 to week 4

Results

Posted May 24, 2012

Participant flow

UF Clinical Research Center. Started March 2008, completed August 2009.

Participant flow — Overall Study
Milestone	1-Fenofibrate Then Placebo	2 Placebo Then Fenofibrate
Started	5	6
Completed	5	6
Not completed	0	0

Outcome measures

PrimaryLog(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

Time frame:: week 12 to week 4
Reported as:: Mean · Log of Ratio

Log(ENA-Period 2 End/ENA Period 1 End)
Log of Ratio	1-Fenofibrate Then Placebo	2 Placebo Then Fenofibrate
Log(ENA-Period 2 End/ENA Period 1 End)	-0.298 ± 0.31	0.178 ± 0.22

Statistical analysis

1-Fenofibrate Then Placebo vs 2 Placebo Then Fenofibrate · t-test, 2 sided · p = 0.015 · Ratio of mean effects: 1.27 · 95% CI 1.06 to 1.52The estimated mean log difference (SE) between the period 2 and period 1 effects and SE was estimated. This estimates twice the effect size\[since (B-A)-(A-B)=2B-2A\] so the actual estimate was based upon the antilog of half of this difference.

Adverse events

Collected over 4 Weeks on Treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
1-Fenofibrate	—	0/11 (0%)	2/11 (18.2%)
2 Placebo	—	0/11 (0%)	2/11 (18.2%)

Most frequent other events

Most frequent other events
Event	1-Fenofibrate	2 Placebo
AbdominalGastrointestinal disorders	2/11	0/11
RashSkin and subcutaneous tissue disorders	0/11	1/11
Nausea/VomitingGastrointestinal disorders	1/11	1/11

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	1-Fenofibrate Then Placebo	2 Placebo Then Fenofibrate	Total
<=18 years	0	0	0
Between 18 and 65 years	5	6	11
>=65 years	0	0	0

Age Continuous
Age Continuous(years)	1-Fenofibrate Then Placebo	2 Placebo Then Fenofibrate	Total
Mean	29.2 ± 17.1	26.0 ± 6.6	27.5 ± 11.9

Sex: Female, Male
Sex: Female, Male(Participants)	1-Fenofibrate Then Placebo	2 Placebo Then Fenofibrate	Total
Female	2	4	6
Male	3	2	5

Region of Enrollment
Region of Enrollment(participants)	1-Fenofibrate Then Placebo	2 Placebo Then Fenofibrate	Total
United States	5	6	11

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00644592
Lead sponsor: University of Florida
Collaborators: American College of Clinical Pharmacy
Responsible party: Sponsor
First posted: Mar 27, 2008
Start date: Mar 2008
Primary completion: Aug 2009
Completion: Aug 2009
Results posted: May 24, 2012
Last update: Jun 1, 2012

Study contacts

Issam Zineh, PharmD

principal investigator · University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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