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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020006-15 | EudraCT Number |
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This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.
The Absorption, Disposition, Metabolism and Excretion of SLV337 will be investigated after a single dose of an oral suspension of 14C-SLV337.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 400 mg suspension |
|
| B | Active Comparator | 5 x 200 mg immediate release capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLV337 suspension | Drug | 400 mg experimental |
| |
| SLV337 capsule |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 (Part 1 and Part 2) | Part 1: 5 days Part 2: 8 days | |
| AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 acyl-glucoronide (Part 2) | Part 2: 8 days | |
| Excretion balance of total 14C-radioactivity (Part 2) | Part 2: 8 days | |
| Total 14C-radioactivity (Part 2) | Part 2: 8 days | |
| Metabolic profiling and identification of 14C-labeled parent compound and metabolites of SLV337 in plasma, urine and feces (Part 2) | Part 2: 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part 1 and Part 2) | Part 1: 19 days Part 2: 15 days |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Anita Vanderlaan | Abbott Healthcare Products BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 61345 | Zuidlaren | 9370 AE | Netherlands |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Drug |
5 x 200 mg immediate release capsule |
|