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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1119-0539 | Other Identifier | WHO | |
| 2011-000146-38 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose (SD) | Experimental | Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation |
|
| Multiple dose (MD) | Experimental | Multiple doses administered s.c. (subcutaneously, under the skin). All subjects will be dosed four times with a dosing frequency of once weekly. Escalation to the next dose level will be based on safety evaluation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somapacitan | Drug | Administered s.c. (subcutaneously, under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (Single Dose) | From first administration of trial product and up until day 40 | |
| Incidence of adverse events (Multiple Dose) | From first administration of trial product and up until day 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the NNC0195-0092 (somapacitan) serum concentration-time curve | From 0 to 168 hours | |
| Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only) | From 0-240 hours |
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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 | Neuss | 41460 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33313798 | Background | Juul Kildemoes R, Hojby Rasmussen M, Agerso H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775. | |
| 29671202 | Derived | Juul RV, Rasmussen MH, Agerso H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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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 |
| C000594654 | NNC0195-0092 |
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| placebo (somapacitan) | Drug | Single or multiple placebo doses administered s.c. (subcutaneously, under the skin) |
|
| Area under the NNC0195-0092 (somapacitan) serum concentration-time curve (SD part only) | up to day 40 |
| Maximum serum concentration (Cmax) for NNC0195-0092 (somapacitan) | up to day 40 |
| Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve | From 0-168 hours |
| Area under the IGF-I (insulin-like growth factor-I) serum concentration-time curve (SD part only) | From 0-240 hours |
| Maximum serum concentration (Cmax) for IGF-I | up to day 40 |
| Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve | From 0-168 hours |
| Area under the IGFBP-3 (insulin-like growth factor binding protein-3) serum concentration-time curve (SD part only) | From 0-240 hours |
| Maximum serum concentration (Cmax) for IGFBP-3 | up to day 40 |
| Number of injection site reactions | From first administration of trial product and up until day 40 (SD part) |
| Number of injection site reactions | From first administration of trial product and up until day 49 (MD part) |
| 25013997 | Derived | Rasmussen MH, Olsen MW, Alifrangis L, Klim S, Suntum M. A reversible albumin-binding growth hormone derivative is well tolerated and possesses a potential once-weekly treatment profile. J Clin Endocrinol Metab. 2014 Oct;99(10):E1819-29. doi: 10.1210/jc.2014-1702. Epub 2014 Jul 11. |
| 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 |