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
  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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 ]

Secondary Outcome Measures:
  • Fenofibric acid levels [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • urinary protein profile [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Claire Nee, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01109758     History of Changes
Other Study ID Numbers: S282.1.002, 2007-006147-52
Study First Received: April 12, 2010
Last Updated: April 22, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Solvay Pharmaceuticals:
Fenofibrate
Gene Expression
DNA methylation

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

ClinicalTrials.gov processed this record on October 20, 2014