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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000096-24 | EudraCT Number | ||
| U1111-1178-1251 | Other Identifier | World Health Organization (WHO) |
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This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somapacitan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somapacitan | Drug | All subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing [3H]-somapacitan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of [3H]-somapacitan related material excreted in urine (% of dose) | Assessed up to 35 days after trial product administration | |
| Total amount of [3H]-somapacitan related material excreted in faeces (% of dose) | Assessed up to 35 days after trial product administration | |
| Total amount of [3H]-somapacitan related material excreted in expired air (% of dose) | Assessed up to 35 days after trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Total recovery of administered 3H label (sum of urine, faeces and expired air) | Assessed up to 36 days after trial product administration | |
| Blood to plasma ratio of [3H]-somapacitan related material | Assessed up to 36 days after trial product administration |
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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 |
|---|---|---|---|
| 34601071 | Derived | Helleberg H, Bjelke M, Damholt BB, Pedersen PJ, Rasmussen MH. Absorption, metabolism and excretion of once-weekly somapacitan, a long-acting growth hormone derivative, after single subcutaneous dosing in human subjects. Eur J Pharm Sci. 2021 Dec 1;167:106030. doi: 10.1016/j.ejps.2021.106030. Epub 2021 Oct 1. |
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| ID | Term |
|---|---|
| C000718308 | somapacitan |
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