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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The primary objective of this study is to assess the pharmacokinetic profile of a single 500 mg dose of SRT2104 administered as an oral suspension and a capsule formulation to normal healthy male and female volunteers in both the fed and fasted state.
The secondary objective is to assess the safety and tolerance of SRT2104 administered as an oral suspension and as a capsule formulation to healthy male and female volunteers in both the fed and fasted state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5g SRT2104 | Experimental | Cohort 1 (10 males) & Cohort 2 (10 females) must attend the clinic on 4 separate treatment visits during the study; each treatment visit will be one week apart. At each treatment visit, subjects will receive one of the following 4 treatments: A) 0.5g SRT2104 administered as an oral suspension in the fasted state B) 0.5g SRT2104 administered as an oral suspension following consumption of a standard meal C) 0.5g SRT2104 administered as two 0.25g capsules in the fasted state D) 0.5g SRT2104 administered as two 0.25g capsules following consumption of a standard meal. For treatments A and C, subjects will have fasted for at least 10 hours overnight. Water will be restricted from 1h prior to dosing until 1h post dose. A light lunch will be provided 4h post dose. For treatments B and D, subjects will receive SRT2104 within 30 min following the start of consumption of a standardized non high-fat meal (approximately 650 kcal with approximately 30% of calories derived from fat). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5g SRT2104 | Drug | SRT2104 will be supplied in two forms: as 0.5g powder which will be prepared by the pharmacist/designee into a liquid suspension and as two hard gelatin capsules, each containing 0.25g SRT2104. The dosing vehicle for the liquid suspension is 1% (by weight) hypromellose acetate succinate in water, which is used as a suspension aid and a dispersant for the SRT2104. Each formulation of test material will be administered orally, in a single dose to the subjects in the fasted state and following consumption of a standard meal. Neither the investigator nor the subjects enrolled will be blinded to treatment assignment. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize and compare the pharmacokinetic profile of a single 500 mg dose of SRT2104 administered as an oral suspension and as a capsule formulation. | PK time points: pre-dose (0 hrs); 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0. 6.0, 8.0, 10, 12, 15, 24, 36, 48, 72 hours post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerance of SRT2104. | AEs, concomitant medications (as applicable), vital signs, physical examinations, laboratory parameters, and ECG parameters will be collected for the duration of the study. |
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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 | Merthyr Tydfill | Glamorgan | CF48 4DR | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22616762 | Background | Hoffmann E, Wald J, Lavu S, Roberts J, Beaumont C, Haddad J, Elliott P, Westphal C, Jacobson E. Pharmacokinetics and tolerability of SRT2104, a first-in-class small molecule activator of SIRT1, after single and repeated oral administration in man. Br J Clin Pharmacol. 2013 Jan;75(1):186-96. doi: 10.1111/j.1365-2125.2012.04340.x. |
| Label | URL |
|---|---|
| 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 |
|---|---|---|---|
| 113261 | Informed Consent Form | 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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| Results for study 113261 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113261 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113261 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113261 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113261 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113261 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113261 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C584666 | SRT2104 |
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