Effects of Fenofibrate on Gene Expression in Healthy Volunteers

Solvay

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Fenofibrate

Study type

Interventional

Funder types

Industry

Identifiers

S282.1.002

2007-006147-52 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

26 patients

Sex

All

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

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