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Effects of Fenofibrate on Gene Expression in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01109758
First Posted: April 23, 2010
Last Update Posted: April 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solvay Pharmaceuticals
  Purpose
The purpose of this study is to assess how fenofibrate modify gene expression in circulating monocytes of healthy volunteers after 6 weeks.

Condition Intervention Phase
Healthy Drug: Fenofibrate Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Fenofibrate on Gene Expression Activity and DNA Methylation Profile in Circulating Monocytes of Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Change of gene activity of markers in circulating monocytes between Baseline and 6 weeks of fenofibrate treatment [ Time Frame: Between Baseline and 6 weeks ]
    The calculation is the difference between the gene expression intensity after 6 weeks of treatment and the gene expression intensity at Baseline

  • DNA methylation pattern [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Fenofibric acid levels [ Time Frame: 6 weeks ]
  • urinary protein profile [ Time Frame: 6 weeks ]

Enrollment: 26
Study Start Date: March 2008
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Fenofibrate
145 mg

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109758


Locations
United Kingdom
Site 1
London, United Kingdom
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Responsible Party: Claire Nee, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01109758     History of Changes
Other Study ID Numbers: S282.1.002
2007-006147-52 ( EudraCT Number )
First Submitted: April 12, 2010
First Posted: April 23, 2010
Last Update Posted: April 23, 2010
Last Verified: April 2010

Keywords provided by Solvay Pharmaceuticals:
Fenofibrate
Gene Expression
DNA methylation

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