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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001769-18 | EudraCT Number | ||
| U1111-1142-0810 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion after a single subcutaneous dose of [3H]-semaglutide in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Subjects will receive a single dose subcutaneously (s.c., under the skin). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of the major metabolites of [3H]-semaglutide in plasma, urine, and faeces | Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of [3H]-semaglutide related material excreted in urine (% of dose) | Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide | |
| Total amount of [3H]-semaglutide related material excreted in faeces (% of dose) | Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Groningen | 9728 NZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28323117 | Result | Jensen L, Helleberg H, Roffel A, van Lier JJ, Bjornsdottir I, Pedersen PJ, Rowe E, Derving Karsbol J, Pedersen ML. Absorption, metabolism and excretion of the GLP-1 analogue semaglutide in humans and nonclinical species. Eur J Pharm Sci. 2017 Jun 15;104:31-41. doi: 10.1016/j.ejps.2017.03.020. Epub 2017 Mar 16. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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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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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| Blood to plasma ratio of [3H]-semaglutide related material | Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide |
| Area under the semaglutide plasma concentration curve | From time 0 until infinity after a single dose |
| Maximum observed semaglutide plasma concentration | After a single dose |