Healthy volunteers are tested in an endotoxemia model
Conditions
Interventions
Trade Name: Zocord 80 mg - Filmtabletten
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Trade Name: CRESTOR
Sponsors
Department of Clinical Pharmacology, Medical University of Vienna
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Men aged between 18 and 45 years -Nonsmokers or smokers =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To determine the effect of HMG-CoA reductase inhibitor pretreatment on inflammation and coagulation activation in human endotoxemia. ;Secondary Objective: -To investigate if anti-inflammatory effects are similar between two different statins. -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) | — |
Countries
Austria
Outcome results
None listed