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Effect of SRT2104 on endotoxin-induced inflammation.

Conditions
Gram negative infection, Sepsis, Lipopolysaccharide, SRT21040, Sirtuins, innate immunity
Registration Number
NL-OMON21773
Lead Sponsor
Academic Medical Center (AMC), Center of Experimental Molecular Medicine
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
24
Inclusion Criteria

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

1. Healthy, as determined by a responsible and experienced physician, based on a
medical evaluation including medical history, physical examination and laboratory tests
carried out within 28 days prior to day 1. A subject with a clinical abnormality or
laboratory parameters outside the reference range for the population being studied may
be included only if the Investigator and the Medical Monitor agree that the finding is
unlikely to introduce additional risk factors and will not interfere with the study
procedures;

Exclusion Criteria

1. Known diseases;

2. A history of smoking within the last six months, or regular consumption of greater than three units of alcohol per day;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary study endpoints include clinical signs and symptoms and laboratory parameters for inflammation (cytokines, activation of leukocytes, coagulation and vascular endothelium).
Secondary Outcome Measures
NameTimeMethod
Secondary endpoints include pharmacokinetics and safety recordings. Exploratory endpoints include lipid profiles, acute phase proteins, metabolic profiles and gene expression analysis from white blood cells. <br>
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