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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50mg SRT2379 | Active Comparator | Single oral administration of 50mg SRT2379 |
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| 250mg SRT2379 | Active Comparator | Single oral administration of 250mg SRT2379 |
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| 1000mg SRT2379 | Active Comparator | Single oral administration of 1000mg SRT2379 |
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| Placebo | Placebo Comparator | Single oral administration of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRT2379 | Drug | SRT2379 is supplied as hard gelatin capsules containing either 25mg or 250mg free-base equivalent of SRT23790 drug substance as its succinate salt. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of SRT2379 will be measured to assess the pharmacokinetics of SRT2379 in healthy male subjects exposed to low-dose endotoxin (LPS). | 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). |
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Inclusion Criteria:
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
Exclusion Criteria:
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
Subject uses tobacco products
Prior participation in a trial where the subject received intravenous endotoxin (LPS) infusion
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Amsterdam | 1105 AZ | Netherlands |
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| Label | URL |
|---|---|
| Results for study 115830 can be found on the GSK Clinical Study Register. | View source |
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 115830 | Clinical Study Report | View IPD |
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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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Placebo | Drug | For the placebo capsules, the SRT2379 drug substance will be replaced by microcrystalline cellulose (Avicel PH200) to visually match the SRT2379 investigational product. |
|
| 34 days |
For additional information about this study please refer to the GSK Clinical Study Register |
| 115830 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115830 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115830 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115830 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115830 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D013568 |
| Pathological Conditions, Signs and Symptoms |