SIMOX - Induction of Oxidative Stress

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of the study is to investigate if use of simvastatin is associated with the level of oxidative stress in humans. The association is examined by comparing changes in oxidative stress in a group treated with simvastatin with the change in a placebo group. The study is a randomized-based, double-blinded placebo-controlled study. Each treatment group consists of 20 healthy male volunteers who consume simvastatin or placebo over 14 days. The induction of oxidative stress is measured by 8-oxoguanosine and 8- oxodeoxyguanosine, isolated from urine. A t-test will be performed to compare drug treatment with placebo. The results will be published.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborators: Klinisk Biokemisk Afdeling; Klinisk farmakologisk Afdeling; Sektion for Biomedicin Institut for Veterinær Patobiologi
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Caucasian

• healthy men

• 18-50 years

• BMI: 18-30

Exclusion Criteria:

• Total cholesterol less than 3 mmol/L

• Use of natural and herbal medicines that is affected/affects simvastatin:

anion exchangers, amiodarone, amlodipine, ciclosporin, clarithromycin, colchicine, danazol, diltiazem, erythromycin, fibrates, fluconazole, fusidin acid, grape fruit juice, HIV protease inhibitors, itraconazole, ketoconazole, nefazodone, niacin, posaconazole, rifampicin, telithromycin, verapamil, vitamin K-antagonists, voriconazole

• following diseases: a Coronary vascular disease b Renal insufficiency c Hepatic insufficiency d heart failure e Previous heart arrythmia f Hypokalaemia g Low blood pressure h hyperthyroidism i muscular toxicity j galactose intolerants k Lapp Lactase deficiency l Glucose/galactose-malabsorption m Psychiatric disorder

• allergies towards any of the tested medicine

• intake of narcotics within 2 months prior to trial

• intake of supplements within 2 months prior to trial