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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 test if SRT2379 may be a novel compound for the treatment of inflammatory disorders in man.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0 g SRT2379 | Active Comparator | Single dose of 1.0g of SRT2379 |
|
| 1.0 g Placebo | Placebo Comparator | Single dose of 1.0g of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRT2379 | Drug | SRT2379 will be supplied as hard gelatin capsules, with each containing 250mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine if a single dose of SRT2379 attenuates the inflammatory response in normal healthy male subjects after exposure to low-dose endotoxin (LPS). | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To determine PK of SRT2379 in normal healthy male subjects exposed to low-dose endotoxin (LPS). | 24 hours | |
| To determine the safety profile of SRT2379 in healthy male subjects exposed to low-dose endotoxin (LPS). | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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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 115083 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 |
|---|---|---|---|
| 115083 | Individual Participant Data Set | 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 | Matching placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo. |
|
For additional information about this study please refer to the GSK Clinical Study Register |
| 115083 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115083 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115083 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115083 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115083 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115083 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D013568 |
| Pathological Conditions, Signs and Symptoms |