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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1187-9141 | Other Identifier | World Health organization (WHO) | |
| 2016-003910-29 | Registry Identifier | EudraCT |
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The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal renal function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal renal function | Experimental | Subjects with normal renal function |
|
| Mild renal impairment | Experimental | Subjects with mild renal impairment |
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| Moderate renal impairment | Experimental | Subjects with moderate renal impairment |
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| Severe renal impairment | Experimental | Subjects with severe renal impairment |
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| Requiring haemodialysis treatment | Experimental | Subjects requiring haemodialysis treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somapacitan | Drug | All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the somapacitan serum concentration time curve | Calculated based on the serum concentrations measured in ug/l | From time 0 to 168 hours after the last dosing on Day 15. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration of somapacitan | Measured in ng/ml | After the last dosing on Day 15 up until Day 43 |
| Time to maximum serum concentration of somapacitan | Calculated based on the serum concentrations measured in ug/l |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33754315 | Derived | Bentz Damholt B, Dombernowsky SL, Dahl Bendtsen M, Bisgaard C, Hojby Rasmussen M. Effect of Kidney or Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Somapacitan: Two Open-Label, Parallel-Group Trials. Clin Pharmacokinet. 2021 Aug;60(8):1015-1027. doi: 10.1007/s40262-021-00990-7. Epub 2021 Mar 23. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| After the last dosing on Day 15 up until Day 43 |
| Incidence of adverse events | Count and % of events | Day 0 - 43 |
| Occurrence of anti-somapacitan antibodies | Count or % of events | Day 0 - 43 |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| 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 |
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| ID | Term |
|---|---|
| C000718308 | somapacitan |
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