SepsisPhase 1NCT01416376
Effect of Multiple Dose Levels 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 determine the effect of a single administration of SRT2379, at multiple-dose levels, on the inflammatory… 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
- 39 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Aug 2011to 12 Dec 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 (PE) 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
- Male between 18 and 35 years of age, inclusive, at the time of signing the informed consent
- Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form
- Chemistry panel, including renal and liver function tests, without any clinically relevant abnormality as judged by the Investigator
- 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
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 unfavourable for enrolment, 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 human immunodeficiency virus (HIV) antibody 1 or 2
- 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 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, THC, methamphetamine) or a positive drug result at the Screening visit
Show all 15Show fewer
- History of alcoholism and/or is drinking more than 3 units of alcohol per day. Alcoholism is defined as an average weekly intake of >21 units for males. 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 received an investigational product within three months of the first dosing day in the current study; Note: any subject who has participated in a prior human endotoxemia study with SRT2379 or SRT2104 would be excluded from participation in this trial.
- Use of prescription or non-prescription drugs and herbal and dietary supplements within 7 days unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise subject safety
- Subject has difficulty donating blood or limited accessibility of a vein in left and 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 Investigator , could be harmful to the subject or compromise interpretation of the data
- Prior participation in a trial where the subject received intravenous endotoxin (LPS) infusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Placebo Controlled, Phase I Dose-ranging Study to Evaluate the Activity of SRT2379 on 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 determine the effect of a single administration of SRT2379, at multiple-dose levels, on the inflammatory response to low dose endotoxin.
- 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 is supplied as hard gelatin capsules containing either 25mg or 250mg free-base equivalent of SRT23790 drug substance as its succinate salt.
PlaceboDrug
For the placebo capsules, the SRT2379 drug substance will be replaced by microcrystalline cellulose (Avicel PH200) to visually match the SRT2379 investigational product.
| Study group | Role | What they receive |
|---|---|---|
| 50mg SRT2379 | Active comparator | Single oral administration of 50mg SRT2379 Receives: Drug: Placebo |
| 250mg SRT2379 | Active comparator | Single oral administration of 250mg SRT2379 Receives: Drug: Placebo |
| 1000mg SRT2379 | Active comparator | Single oral administration of 1000mg SRT2379 Receives: Drug: SRT2379 |
| Placebo | Placebo comparator | Single oral administration of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical signs and symptoms of inflammation will be used as a measure of the effect of multiple-dose levels of SRT2379 on the inflammatory response in normal healthy male subjects exposed to low-dose endotoxin (LPS).
Measured: 12 days
Laboratory parameters of inflammation will be used as a measure of the effect of multiple-dose levels of SRT2379 on the inflammatory response in normal healthy male subjects exposed to low-dose endotoxin (LPS).
Measured: 12 days
Secondary outcomes (2)
Plasma levels of SRT2379 will be measured to assess the pharmacokinetics of SRT2379 in healthy male subjects exposed to low-dose endotoxin (LPS).
Measured: 2 days
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of multiple-dose levels of SRT2379 in healthy male subjects exposed to low-dose endotoxin (LPS).
Measured: 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study start30 Aug 2011
- Primary completion12 Dec 2011
- Study completion12 Dec 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
- 39 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
- NCT01416376
- Sponsor's protocol ID
- 115830
- Status last verified
- Jun 2017
- First submitted
- 28 Jul 2011
- Last updated
- 15 Jun 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 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled, Phase I Dose-ranging Study to Evaluate the Activity of SRT2379 on Endotoxin Induced Inflammatory Response in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01416376
- Acronym / sponsor ID
- 115830
- Conditions
- Sepsis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Sirtris, a GSK CompanyIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 30 Aug 2011 (actual)
- Primary completion
- 12 Dec 2011 (actual)
- Study completion
- 12 Dec 2011 (actual)
- First posted
- 15 Aug 2011 (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 determine the effect of a single administration of SRT2379, at multiple-dose levels, on the inflammatory response to low dose endotoxin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 50mg SRT2379 | Active comparator | Drug: PlaceboSingle oral administration of 50mg SRT2379 |
| 250mg SRT2379 | Active comparator | Drug: PlaceboSingle oral administration of 250mg SRT2379 |
| 1000mg SRT2379 | Active comparator | Drug: SRT2379Single oral administration of 1000mg SRT2379 |
| Placebo | Placebo comparator | Drug: PlaceboSingle oral administration 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 (PE) 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
- Male between 18 and 35 years of age, inclusive, at the time of signing the informed consent
- Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form
- 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
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 unfavourable for enrolment, 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 human immunodeficiency virus (HIV) antibody 1 or 2
- Subject has donated more than 350 mL of blood in last 3 months
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 is supplied as hard gelatin capsules containing either 25mg or 250mg free-base equivalent of SRT23790 drug substance as its succinate salt. | Drug | 1000mg SRT2379 |
| PlaceboFor the placebo capsules, the SRT2379 drug substance will be replaced by microcrystalline cellulose (Avicel PH200) to visually match the SRT2379 investigational product. | Drug | 250mg SRT2379, 50mg SRT2379, Placebo |
Primary outcome
Clinical signs and symptoms of inflammation will be used as a measure of the effect of multiple-dose levels of SRT2379 on the inflammatory response in normal healthy male subjects exposed to low-dose endotoxin (LPS).
Time frame: 12 days
Laboratory parameters of inflammation will be used as a measure of the effect of multiple-dose levels of SRT2379 on the inflammatory response in normal healthy male subjects exposed to low-dose endotoxin (LPS).
Time frame: 12 days
2 secondary outcomes
Plasma levels of SRT2379 will be measured to assess the pharmacokinetics of SRT2379 in healthy male subjects exposed to low-dose endotoxin (LPS).
Time frame: 2 days
Number of participants with adverse events and incidence of adverse events will be used as a measure of safety and tolerability of multiple-dose levels of SRT2379 in healthy male subjects exposed to low-dose endotoxin (LPS).
Time frame: 34 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 15 Jun 2017.
- Results for study 115830 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.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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 15 Jun 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?
Clinical signs and symptoms of inflammation will be used as a measure of the effect of multiple-dose levels of SRT2379 on the inflammatory response in normal healthy male subjects exposed to low-dose endotoxin (LPS). (time frame: 12 days). The study lists 2 primary outcomes in all. 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 15 Jun 2017.