Effects of Fenofibrate on Gene Expression in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Fenofibrate

• Registration Number: NCT01109758
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-07
• Study Completion: 2008-08
• Status Verified: 2010-04
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-22
• Last Update Submitted: 2010-04-22
• Study First Posted: 2010-04-23
• Last Update Posted: 2010-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Fenofibrate	-

Primary Outcome Measures

Name	Time	Method
Change of gene activity of markers in circulating monocytes between Baseline and 6 weeks of fenofibrate treatment	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	6 weeks

Secondary Outcome Measures

Name	Time	Method
Fenofibric acid levels	6 weeks
urinary protein profile	6 weeks

Trial Locations

Locations (1)

Site 1; 🇬🇧 London, United Kingdom