Expired Study
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Saint Louis, Missouri 63110


Purpose:

In this randomized, double-blind, placebo controlled trial we will utilize positron emission tomography to determine if lovastatin or recombinant human activated protein C exhibit anti-inflammatory effects in humans following intrabronchial installation of lipopolysaccharide (LPS or endotoxin)


Criteria:

Inclusion Criteria: - Healthy, man or woman, any race or ethnicity, age 19 - 44 years old - Screening FEV1 and FVC must be > 80% of predicted. - Screening oxygen saturation by pulse oximetry is >97% on room air. - Research volunteer must be capable of lying still and supine within the PET scanner for ~2 ½ hours. - Research volunteer must be capable of fasting for 6 hours. Exclusion Criteria: - Pregnancy (confirmed by a qualitative urine hCG pregnancy test) - Lactation. - Actively menstruating at time of randomization - History of tobacco use or has smoked other illicit drugs (marijuana, cocaine) in the past year. - Research volunteer is currently taking any prescription medications. - Research volunteer is at increased risk for radiation exposure (e.g. flight attendants) - Research volunteer is enrolled in another research study of an investigational drug. - Research volunteer has a known allergy to both trimethoprim/sulfamethoxazole and amoxicillin. - Research volunteer has a known allergy to drugs routinely used during bronchoscopy. - Research volunteer has a known allergy to lovastatin or rhAPC - Fasting glucose at time of PET study > 150 mg/dl. - Exclusion criteria related to use of rhAPC: - Active or history of internal bleeding within the past 3 months - History of hemorrhagic stroke within the past 3 months. - History of intracranial or instraspinal surgery, or severe head trauma, within the past 3 months - History of trauma with an increased risk of life-threatening bleeding within the past 3 months - History of receiving thrombolytic therapy within the past 3 months. - History of receiving oral anticoagulants or glycoprotein IIb/IIIa inhibitors within the past 3 months. - History of using aspirin > 650 mg/d or other platelet inhibitors within the past 7 days. - Any history of intracranial arteriovenous malformation or aneurysm - Any history of a known bleeding diathesis - Any history of chronic severe hepatic disease - Presence of an epidural catheter - Any history of intracranial neoplasm or mass lesion or evidence of cerebral herniation - Use of heparin during past 7 days - Platelet count <100,000 x 106/L - Prothrombin time-INR > 1.5 - SGOT >47 IU/L, SGPT > 53 IU/L, or bilirubin > 1.1 mg/dl - Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location. - Exclusion criteria related to use of lovastatin: - History of chronic active liver disease or acute liver disease within the past 3 months - SGOT >47 IU/L, SGPT > 53 IU/L, or bilirubin > 1.1 mg/dl.


NCT ID:

NCT00741013


Primary Contact:

Principal Investigator
Micahel J Walter, MD
Washington University School of Medicine


Backup Contact:

N/A


Location Contact:

Saint Louis, Missouri 63110
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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