Effects of Fenofibrate on Gene Expression in Healthy Volunteers
2 other identifiers
interventional
26
1 country
1
Brief Summary
The purpose of this study is to assess how fenofibrate modify gene expression in circulating monocytes of healthy volunteers after 6 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Mar 2008
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 12, 2010
CompletedFirst Posted
Study publicly available on registry
April 23, 2010
CompletedApril 23, 2010
April 1, 2010
4 months
April 12, 2010
April 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Fenofibric acid levels
6 weeks
urinary protein profile
6 weeks
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Site 1
London, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 12, 2010
First Posted
April 23, 2010
Study Start
March 1, 2008
Primary Completion
July 1, 2008
Study Completion
August 1, 2008
Last Updated
April 23, 2010
Record last verified: 2010-04