Effects of Fenofibrate on Gene Expression in Healthy Volunteers

• Sponsor: Solvay Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01109758
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Fenofibrate	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• 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
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Fenofibrate; 145 mg

Outcome Measures

Primary Outcome Measures

1. 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

2. DNA methylation pattern [6 weeks]

Secondary Outcome Measures

1. Fenofibric acid levels [6 weeks]

2. urinary protein profile [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Site 1	London		United Kingdom

Sponsors and Collaborators

• Solvay Pharmaceuticals

Investigators

• Study Director: Global Clinical Director Solvay, Solvay Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01109758
• Other Study ID Numbers: S282.1.002; 2007-006147-52
• First Posted: Apr 23, 2010
• Last Update Posted: Apr 23, 2010
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: Fenofibrate; Gene Expression; DNA methylation
• Additional relevant MeSH terms: Fenofibrate

Study Results

No Results Posted as of Apr 23, 2010