SepsisPhase 1NCT01262911
Effect of SRT2379 on Endotoxin-Induced Inflammation
A Phase 1 study testing SRT2379 in people with Sepsis, run by Sirtris, a GSK Company at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- SRT2379
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Feb 2011to 26 Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sepsis
- Being tested
- SRT2379, Placebo
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRT2379Drug
SRT2379 will be supplied as hard gelatin capsules, with each containing 250mg.
PlaceboDrug
Matching placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo.
| Study group | Role | What they receive |
|---|---|---|
| 1.0 g SRT2379 | Active comparator | Single dose of 1.0g of SRT2379 Receives: Drug: SRT2379 |
| 1.0 g Placebo | Placebo comparator | Single dose of 1.0g of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if a single dose of SRT2379 attenuates the inflammatory response in normal healthy male subjects after exposure to low-dose endotoxin (LPS).
Measured: 24 hours
Secondary outcomes (2)
To determine PK of SRT2379 in normal healthy male subjects exposed to low-dose endotoxin (LPS).
Measured: 24 hours
To determine the safety profile of SRT2379 in healthy male subjects exposed to low-dose endotoxin (LPS).
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study start17 Feb 2011
- Primary completion26 Apr 2011
- Study completion26 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirtris, a GSK Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262911
- Sponsor's protocol ID
- 115083
- Status last verified
- Aug 2017
- First submitted
- 16 Dec 2010
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate a Single Oral Dose of SRT2379 on the Endotoxin Induced Inflammatory Response in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01262911
- Acronym / sponsor ID
- 115083
- Conditions
- Sepsis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sirtris, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 17 Feb 2011 (actual)
- Primary completion
- 26 Apr 2011 (actual)
- Study completion
- 26 Apr 2011 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.0 g SRT2379 | Active comparator | Drug: SRT2379Single dose of 1.0g of SRT2379 |
| 1.0 g Placebo | Placebo comparator | Drug: PlaceboSingle dose of 1.0g of placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRT2379SRT2379 will be supplied as hard gelatin capsules, with each containing 250mg. | Drug | 1.0 g SRT2379 |
| PlaceboMatching placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo. | Drug | 1.0 g Placebo |
Primary outcome
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
2 secondary outcomes
To determine PK of SRT2379 in normal healthy male subjects exposed to low-dose endotoxin (LPS).
Time frame: 24 hours
To determine the safety profile of SRT2379 in healthy male subjects exposed to low-dose endotoxin (LPS).
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Results for study 115083 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SRT2379 in people with Sepsis, run by Sirtris, a GSK Company at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.