Anti-Inflammatory Effect of Statins in the Human Endotoxin Model

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the effects of HMG-CoA reductase inhibitor pretreatment on inflammation and coagulation activation in human endotoxemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Anti-Inflammatory Agents; Rosuvastatin Calcium; Simvastatin

Criteria

Inclusion Criteria:

• Men aged between 18 and 45 years

• Nonsmokers or smokers <5 cig/d

• Body mass index between 18 and 30; respectively weight ≤ 95 kilograms

• Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

• Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study

• Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia

• Treatment in the previous 3 weeks with any drug

• Symptoms of a clinically relevant illness in the 3 weeks before the first study day

• History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs

• Blood donation during the previous 3 weeks

• History of hypersensitivity to the trial drug or to drugs with a similar chemical structure