Table 1.
Clinical trials involving SRT2104.
| Main ID | Phase of study | Target sample size | Model | Public title | Time | Primary sponsor | Countries of recruitment |
|---|---|---|---|---|---|---|---|
| NCT01702493 | I | 16 | Healthy male volunteers between 16 and 65 years of age | A Study to Assess the Relative Bioavailability of New Oral Formulations of SRT2104 in Healthy Male Volunteers | 2012-10-30 to 2012-12-05 | Sirtris, a GSK Company | United States |
| NCT01453491 | I | 17 | Patients with ulcerative colitis between 16 and 75 years of age | Assess the Safety and Anti-inflammatory Effects of Two Different Doses of SRT2104 in Patients With Ulcerative Colitis | 2012-02-13 to 2013-03-18 | Sirtris, a GSK Company | United States |
| NCT01154101 | II | 40 | Moderate to Severe Plaque-Type Psoriasis between 18 and 80 years of age | Study of the Clinical Activity, Safety, and Tolerability of SRT2104 in Subjects With Moderate to Severe Plaque-Type Psoriasis | 2010-06-07 to 2011-11-09 | Sirtris, a GSK Company | United States |
| NCT01039909 | I | 0 | Healthy Human Volunteers between 18 and 40 years of age | A Clinical Study to Assess the Effects of SRT2104 Upon Immobilization-Induced Skeletal Muscle Atrophy in Healthy Human Volunteers | 2009-12-25 | GlaxoSmithKline | – |
| NCT01031108 | I | 38 | Healthy Cigarette Smokers and Subjects With Type 2 Diabetes Mellitus between 18 and 70 years of age | A Clinical Trial to Assess the Safety of Oral SRT2104 and Its Effects on Vascular Dysfunction in Otherwise Healthy Cigarette Smokers and Subjects With Type 2 Diabetes Mellitus | 2010-05-28 to 2011-10-12 | Sirtris, a GSK Company | United Kingdom |
| NCT01018017 | II | 86 | Type 2 Diabetes Mellitus between 18 and 35 years of age | A Clinical Study to Assess the Safety, Tolerability, and Activity of Oral SRT2104 Capsules Administered for 28 Days to Subjects With Type 2 Diabetes Mellitus | 2009-12-09 to 2010-05-10 | GlaxoSmithKline | Germany |
| NCT01014117 | I | 41 | Healthy Male Subjects between 18 and 35 years of age | Effect of SRT2104 on Endotoxin-induced Inflammation | 2009-12-09 To 2010-05-10 | GlaxoSmithKline | Netherlands |
| NCT00964340 | I | 24 | Healthy Elderly Subjects between 60 and 80 years of age | A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral SRT2104 Capsules Administered to Healthy Elderly Subjects for 28 Days | 2009-10-01 to 2010-04-27 | GlaxoSmithKline | United Kingdom |
| NCT00937872 | I | 9 | Healthy Male Subjects between 18 and 65 years of age | A Clinical Study to Evaluate the Pharmacokinetics and the Absolute Bioavailability of SRT2104 Given as a 250 mg Oral Suspension and Intravenous Microdose of 100 µg Carbon-14 Radio-labeled SRT2104 in Healthy Male Subjects | 2008-11-22 to 2008-12-22 | Sirtris, a GSK Company | United Kingdom |
| NCT00938275 | I | 20 | Normal Healthy Volunteers between 18 and 55 years of age | A Clinical Study to Assess the Effect of Food and Gender on the Pharmacokinetics of SRT2104 Administered as an Oral Suspension or Capsule Formulation to Normal Healthy Volunteers | 2009-01-20 to 2009-03-27 | Sirtris, a GSK Company | United Kingdom |
| NCT00937326 | II | 227 | Type 2 Diabetic Human Subjects between 30 to 70 years of age | Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects | 2009-08-19 to 2010-09-18 | Sirtris, a GSK Company | Bulgaria, Estonia, Hungary, Poland, Romania, Russian Federation, Ukraine, United Kingdom |
| NCT00933530 | I | 43 | Normal Healthy Male Volunteers between 18 and 55 years of age | A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Normal Healthy Male Volunteers | 2008-05 to 2008-11 | Sirtris, a GSK Company | United Kingdom |
| NCT00933062 | I | 10 | Normal Healthy Male Volunteers between 28 and 60 years of age | Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of SRT2104 Administered to Normal Healthy Male Volunteers | 2009-03-23 to 2009-05-12 | GlaxoSmithKline | United Kingdom |
| NCT00920660 | I | 20 | Healthy Volunteers between 18 and 60 years of age | Clinical Study to Assess the Effects of SRT2104 and Prednisolone on Biomarkers in Blood in Healthy Volunteers | 2009-04-06 to 2009-06-12 | GlaxoSmithKline | United Kingdom |
| EUCTR2009-010720-26-GB | II | 225 | Type 2 Diabetic Human Subjects between 30 and 70 years of age | A Phase II, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects | 2009-08-19 to 2010-09-18 | Sirtris Pharmaceuticals, Inc | Bulgaria, Estonia, Hungary, Poland, United Kingdom |
| EUCTR2009-016537-98-DE | II | 80 | Type 2 Diabetes Mellitus between 18 and 65 years of age | Study to Assess the Safety, Tolerability and Activity of Oral SRT2104 Capsules Administered for 28 days to Subjects with Type 2 Diabetes Mellitus | 2010-03-03 to 2010-12-25 | Sirtris Pharmaceuticals Inc | Germany |
| NTR1971 | I | 24 | Healthy Male Subjects between 18 and 35 years of age | Evaluate single and multiple (seven) oral doses of SRT2104 on the Endotoxin induced inflammatory response in Healthy Male Subjects | 2009-11-01 to 2010-01-11 | Academic Medical Center, Center of Experimental Molecular Medicine | Amsterdam |