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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003670-27 | Registry Identifier | European Medicines Agency (EudraCT) | |
| U1111-1220-5197 | Registry Identifier | World Health Organization (WHO) |
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This study will compare two strengths of the new long-acting growth hormone somapacitan. The aim of this study is to test if both strengths are taken up in the blood in the same way. During three separate dosing visits participants will get a total of 3 injections of the study medicine. Somapacitan is not yet approved and therefore cannot be prescribed by a doctor outside of this study. The study duration is between 10 and 15 weeks. Participants will have 17 visits with the study doctor. Three visits will each comprise 6 in-house days with overnight stays. In total, at least 15 overnight stays at the clinic. There will be blood samplings during the study. Participants must come to the clinic regularly for these blood samplings. People who have already received growth hormones in the past or who are growth hormone deficient cannot be in the study. People cannot be in the study if the study doctor thinks that there are risks for their health. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somapacitan 5/10/10 mg | Experimental | One dose of somapacitan 5 mg/1.5 ml followed by two doses of somapacitan 10 mg/1.5 ml. Each dose will be followed by a 3 week observation period. |
|
| Somapacitan 10/5/10 mg | Experimental | One dose of somapacitan 10 mg/1.5 ml followed by a 5 mg/1.5 ml dose followed by a 10 mg/1.5 ml dose. Each dose will be followed by a 3 week observation period. |
|
| Somapacitan 10/10/5 mg | Experimental | Two doses of 10 mg/1.5 ml somapacitan followed by a 5 mg/1.5 ml dose. Each dose will be followed by a 3 week observation period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somapacitan | Drug | 5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the somapacitan serum concentration time curve from time 0 to the time of the last quantifiable concentration after dosing | ng*h/mL | 0 to 504 hours after trial product administration |
| Maximum serum concentration of somapacitan | ng/mL | 0 to 504 hours after trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the somapacitan serum concentration time curve from time 0 to 168 hours after dosing | ng*h/mL | 0 to 168 hours after trial product administration |
| Area under the somapacitan serum concentration time curve from time 0 to infinity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Neuss | 41460 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38969919 | Derived | Dombernowsky SL, Damholt BB, Hojby Rasmussen M, Svaerke C, Kildemoes RJ. Investigating the Bioavailability and Insulin-like Growth Factor-I Release of Two Different Strengths of Somapacitan: A Randomised, Double-Blind Crossover Trial. Clin Pharmacokinet. 2024 Jul;63(7):1015-1024. doi: 10.1007/s40262-024-01395-y. Epub 2024 Jul 5. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C000718308 | somapacitan |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
ng*h/mL
| 0 to 504 hours after trial product administration |
| Time to maximum serum concentration of somapacitan | Hours | 0 to 504 hours after trial product administration |
| Terminal half-life of somapacitan | Hours | 0 to 504 hours after trial product administration |
| Area under the insulin-like growth factor I (IGF-I) serum concentration time curve from time 0 to 168 hours after dosing | ng*h/mL | 0 to 168 hours after trial product administration |
| Maximum serum concentration of IGF-I after dosing | ng/mL | 0 to 504 hours after trial product administration |
| Time to maximum serum concentration of IGF-I after dosing | Hours | 0 to 504 hours after trial product administration |
| D001849 |
| Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |