Effect of SRT2379 on Endotoxin-Induced Inflammation

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01262911
First received: December 16, 2010
Last updated: July 26, 2011
Last verified: July 2011

December 16, 2010
July 26, 2011
February 2011
March 2011   (final data collection date for primary outcome measure)
To determine if a single dose of SRT2379 attenuates the inflammatory response in normal healthy male subjects after exposure to low-dose endotoxin (LPS). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01262911 on ClinicalTrials.gov Archive Site
  • To determine PK of SRT2379 in normal healthy male subjects exposed to low-dose endotoxin (LPS). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • To determine the safety profile of SRT2379 in healthy male subjects exposed to low-dose endotoxin (LPS). [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of SRT2379 on Endotoxin-Induced Inflammation
A Phase I Study to Evaluate a Single Oral Dose of SRT2379 on the Endotoxin Induced Inflammatory Response in Healthy Male Subjects

SRT2379 is a potent small molecule activator of SIRT1 that has been found to inhibit systemic inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice. The objective of this study is to test if SRT2379 may be a novel compound for the treatment of inflammatory disorders in man.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Sepsis
  • Drug: SRT2379
    SRT2379 will be supplied as hard gelatin capsules, with each containing 250mg.
  • Drug: Placebo
    Matching placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo.
  • Active Comparator: 1.0 g SRT2379
    Single dose of 1.0g of SRT2379
    Intervention: Drug: SRT2379
  • Placebo Comparator: 1.0 g Placebo
    Single dose of 1.0g of placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 dosing.
  • Male between 18 and 35 years of age inclusive, at the time of signing the informed consent
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
  • Chemistry panel, including renal and liver functions tests, without any clinically relevant abnormality
  • Subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 7 days following the dose of study drug

Exclusion Criteria:

  • Subject has had a major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavorable for enrollment including inflammatory diseases
  • Subjects with a history of any type of malignancy with the exception of successfully treated basal cell cancer of the skin
  • Subject has a past or current gastrointestinal disease which may influence drug absorption
  • The subject has a known positive test for hepatitis C antibody, hepatitis B surface antigen or HIV
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • 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
  • 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
  • The subject has participated in a clinical trial and has received an investigational product within three months of the dosing in the current study
  • 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
  • Subject has difficultly in donating blood or accessibility of a vein in left or right arm
  • Subject has donated more than 350 mL of blood in last 3 months
  • Subject uses tobacco products
  • Any clinically relevant abnormality noted on the 12-lead ECG as judged by the investigator or an average QTcB or QTcF > 450 msec
  • Any other issue that, in the opinion of the Principal Investigator, would could be harmful to the subject or compromise interpretation of the data
  • Prior participation in a trial where the subject received IV LPS
Male
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01262911
115083
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
Sirtris, a GSK Company
GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP