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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The primary objective of this study is to determine the absolute bioavailability of SRT2104 as a 250 mg suspension, and to define the intravenous pharmacokinetics of SRT2104.
The secondary objective of this study is to assess the potential systemic metabolite burden of SRT2104, and to provide plasma and urine samples for subsequent metabolite profiling and identification.
This will be a single centre, combined IV and oral single dose, open-label study in healthy male volunteers.
Each subject will receive the following formulations on a single study day:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRT2104 | Experimental | Single arm with crossover from single dose of oral suspension formulation to single dose intravenous formulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 250 mg SRT2104 Suspension | Drug | Single 10 mL oral dose of 250 mg SRT2104 delivered as a suspension formulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute bioavailability of SRT2104 250 mg suspension. | Time points to measure the bioavailability of SRT2104 oral 250 mg suspension: 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72 hrs following administration. | |
| Define the intravenous pharmacokinetics of SRT2104. | Time points to define the IV PK of SRT2104: Just before infusion (0); During infusion (5, 10 min); Post infusion (5, 10, 20, 30, 45 min and 1, 2, 3, 4, 6, 8, 10, 12, 15, 21, 45, 69 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| Potential systemic metabolite burden of SRT2104 following administration. | At time points: Pre-dose; 0-12 hrs post dose; 12-24 hrs post dose). |
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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 | Nottingham | NG11 6JS | United Kingdom |
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| Carbon-14 radio-labeled SRT2104 | Drug | Single 10 mL IV dose containing 100 microgram (not more than 250 nCi, 9.25 kBq) Carbon-14 radio-labeled SRT2104, administered by IV infusion over 15 minutes, starting 2 hours and 45 minutes after the oral dose is administered. |
|
| 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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