Anti-inflammatory effect of statins in the human endotoxin model - Statins in Human Endotoxemia

Conditions: Healthy volunteers are tested in an endotoxemia model

Registration Number: EUCTR2005-003041-14-AT

Lead Sponsor: Department of Clinical Pharmacology, Medical University of Vienna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 6

Inclusion Criteria

-Men aged between 18 and 45 years
-Nonsmokers or smokers <10 cig/d
-Body mass index between 15th and 85th percentile (Must et al. 1991)
-Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: -To determine the effect of HMG-CoA reductase inhibitor pretreatment on inflammation and coagulation activation in human endotoxemia.<br>;Secondary Objective: -To investigate if anti-inflammatory effects are similar between two different statins.<br>-To study genome-wide effects on the leukocyte transcriptome induced by (i) statin pretreatment, (ii) low-dose endotoxemia, and (iii) the anti-inflammatory effects if the statins ;Primary end point(s): Thrombus formation (D-dimer content of degraded ex vivo thrombus), monocyte CRP production, leukocyte mRNA expression profiles (human genome GeneChip arrays)

Secondary Outcome Measures