The Effect of a Peroxisome Proliferator-activated Receptor (PPAR) Alpha Agonist on Cytochrome P450 (CYP) Monooxygenase Activity in Humans

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis is to test to see if the drug fenofibrate will increase important chemicals in the body and specifically in the kidney, help to rid the body of salt by the kidneys, decrease blood pressure and improve insulin sensitivity during high-salt intake in individuals with hypertension.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: National Institutes of Health (NIH)
• Treatments: Fenofibrate

Criteria

Inclusion Criteria:

• Ambulatory subjects, 18-70 years of age, inclusive

• For female subjects, the following conditions must be met Postmenopausal status for at least 1 year, or Status post surgical sterilization, or If of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day

Exclusion Criteria:

• Secondary causes of hypertension

• Diabetes type 1 or type 2 as defined by a fasting glucose of 126 mg/dl or greater or the use of anti-diabetic medication

• Use of hormone replacement therapy

• Statin or fibrate therapy

• A seated systolic blood pressure(SBP) greater than 179 mmHg or a seated diastolic blood pressure(DBP) greater than 110 mmHg

• Pregnancy

• Breast-feeding

• Cardiovascular disease such as history of myocardial infarction, presence of angina pectoris, significant arrhythmia, congestive heart failure, (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy

• Treatment with anticoagulants

• History of serious neurologic diseases such as cerebral hemorrhage,stroke, or transient ischemic attack

• History or presence of immunological or hematological disorders

• Diagnosis of asthma

• Clinically significant gastrointestinal impairment that could interfere with drug absorption

• Impaired hepatic function (aspartate aminotransferase [AST] and or alanine aminotransferase [ALT] > 2.0 x upper range)

• Known preexisting gallbladder disease

• Impaired renal function (eGFR < 60 ml/min/1.73M2)

• Hematocrit < 35%

• Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult

• Treatment with a glucocorticoid therapy

• Treatment with lithium salts

• History of of alcohol or drug abuse

• Treatment with any investigational drug in the 1 month preceding the study

• Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study

• Inability to comply with the protocol, e.g uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study