A Phase I study to evaluate a single oral dose of SRT2379 on the endotoxin induced inflammatory response in healthy male subjects

• Conditions: Door endotoxine veroorzaakte inflammatie reactie; Inflammation; innate immunesystem; 10002252

• Registration Number: NL-OMON36662
• Lead Sponsor: Sirtris Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 16

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 21 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.
2. Male between 18 and 35 years of age inclusive, at the time of signing the informed consent
3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
4. Chemistry panel including renal and liver function tests without any clinically relevant abnormality as judged by the Investigator.
5. Subjects must agree to use double-barrier birth control or abstinence while participating in the study and for 7 days following the last dose of study drug

Exclusion Criteria

1. Subject has had a major illness in the past three months or any significant chronic medial illness that the investigator would deem unfavourable for enrolment including inflammatory diseases
2. Subjects with a history of any type of malignancy with the exception of successfully treated basal cell cancer of the skin
3. Subject has a past or current gastro-intestinal disease which may influence drug absorption
4. The subject has a known positive test for hepatitis C antibody or hepatitis B surface antigen or human immunodeficiency virus (HIV) antibody 1 or 2.
5. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
6. Subject has a history, within three years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, THC) or a positive drug results at the Screening visit
7. History of alcoholism and/or is drinking more than 3 drinks per day. Alcoholism is defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits
8. The subject has participated in a clinical trial and has received an investigational product within three months of the first dosing day in the current study
9. Use of prescription or non-prescription drugs, and herbal and dietary supplements within 7 days unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with the study procedures or compromise subject safety
10. Subject has difficultly in donating blood or accessibility of a vein in left or right arm
11. Subject has donated more than 350 mL of blood in last 3 months
12. Subject uses tobacco products
13. Any clinically relevant abnormality noted on the 12-lead ECG as judged by the Investigator or an average QTcB or QTcF < 450 msec
14. Any other issue that, in the opinion of the Principal Investigator, would could be harmful to the subject or compromise interpretation of the data
15. Prior participation in a trial where the subject received intravenous endotoxin (LPS) infusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoints include clinical signs and symptoms and laboratory<br /><br>parameters for inflammation (cytokines, activation of leukocytes, coagulation<br /><br>and vascular endothelium). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Secondary endpoints include pharmacokinetics and safety recordings.<br /><br>Exploratory endpoints include lipid profiles, acute phase proteins, metabolic<br /><br>profiles and gene expression analysis from white blood cells. </p><br>