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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01109758

Enrollment

Registered

2010-04-23

Start date

2008-03-31

Completion date

2008-08-31

Last updated

2010-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Fenofibrate, Gene Expression, DNA methylation

Brief summary

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

Interventions

DRUGFenofibrate

145 mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Fenofibric acid levels	6 weeks
urinary protein profile	6 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026