Last updated: 11/07/2018 08:35:17
Effect of SRT2379 on Endotoxin-Induced Inflammation
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase I Study to Evaluate a Single Oral Dose of SRT2379 on the Endotoxin Induced Inflammatory Response in Healthy Male Subjects
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
To determine if a single dose of SRT2379 attenuates the inflammatory response in normal healthy male subjects after exposure to low-dose endotoxin (LPS).
Timeframe: 24 hours
Secondary outcomes:
To determine PK of SRT2379 in normal healthy male subjects exposed to low-dose endotoxin (LPS).
Timeframe: 24 hours
To determine the safety profile of SRT2379 in healthy male subjects exposed to low-dose endotoxin (LPS).
Timeframe: 10 days
Interventions:
Enrollment:
17
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sepsis
Product
GSK2245841
Collaborators
GSK
Study date(s)
February 2011 to April 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 35 years
Accepts healthy volunteers
Yes
- 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
- 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
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2011-26-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 115083 can be found on the GSK Clinical Study Register.
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