Effects of Fenofibrate on Gene Expression in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to assess how fenofibrate modify gene expression in circulating monocytes of healthy volunteers after 6 weeks.

Official Title
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Effects of Fenofibrate on Gene Expression Activity and DNA Methylation Profile in Circulating Monocytes of Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Fenofibrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, To be aged 40-65 years, To be post menopausal female not receiving hormone replacement therapy, To have normal homocysteine, folate and vitamin B12 levels at baseline (results available for initiation of treatment), To be in good health as determined by medical history, physical examination, ECG, vital signs, serum/urine biochemistry and hematology. Exclusion Criteria: Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, neurologic/psychiatric or emotional, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, (drug) allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking the study medication, Subjects who have been treated with fenofibrate in a previous study, Subjects who have taken a single dose of an investigational drug within 30 days or multiple doses of any investigational drug within 60 days prior to dosing

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Fenofibrate<br>* 145 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of gene activity of markers in circulating monocytes between Baseline and 6 weeks of fenofibrate treatment | The calculation is the difference between the gene expression intensity after 6 weeks of treatment and the gene expression intensity at Baseline | Between Baseline and 6 weeks | 
| DNA methylation pattern |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fenofibric acid levels |  | 6 weeks | 
| urinary protein profile |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fenofibrate, Gene Expression, DNA methylation