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Effects of Fenofibrate on Gene Expression in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01109758
First received: April 12, 2010
Last updated: April 22, 2010
Last verified: April 2010
History of Changes

April 12, 2010
April 22, 2010
March 2008
July 2008   (final data collection date for primary outcome measure)
  • Change of gene activity of markers in circulating monocytes between Baseline and 6 weeks of fenofibrate treatment [ Time Frame: Between Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01109758 on ClinicalTrials.gov Archive Site
  • Fenofibric acid levels [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • urinary protein profile [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Fenofibrate on Gene Expression in Healthy Volunteers
Effects of Fenofibrate on Gene Expression Activity and DNA Methylation Profile in Circulating Monocytes of Healthy Volunteers

The purpose of this study is to assess how fenofibrate modify gene expression in circulating monocytes of healthy volunteers after 6 weeks.
Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
Drug: Fenofibrate
145 mg
Experimental: 1
Intervention: Drug: Fenofibrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
August 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
40 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01109758
S282.1.002, 2007-006147-52
No
Claire Nee, Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP