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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1187-9247 | Other Identifier | World Health Organization (WHO) | |
| 2016-003911-36 | Registry Identifier | EudraCT |
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This trial is conducted in Europe. The aim of this trial is to investigate the effect of abnormal liver (hepatic) function on the amount of trial drug getting into the body and removal of the drug from the body (this is called pharmacokinetics).
In this trial the participants will receive three subcutaneous (under the skin) injections of the trial drug somapacitan. Somapacitan is a long-acting growth hormone analogue (a drug similar to human growth hormone) intended for once-weekly subcutaneous administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal hepatic function | Experimental | Subjects with normal hepatic function |
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| Mild hepatic impairment | Experimental | Subjects with mild hepatic impairment |
|
| Moderate hepatic impairment | Experimental | Subjects with moderate hepatic impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somapacitan | Drug | 3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the somapacitan serum concentration time curve | Calculated based on somapacitan measured in blood | From time 0 to 168 hours after the last dosing on Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration of somapacitan | Calculated based on plasma somapacitan activity measured in blood | After the last dosing on Day 15 until Day 43 |
| Time to maximum serum concentration of somapacitan |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Bratislava | 83101 | Slovakia |
| 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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Sponsor staff involved in the clinical trial is masked according to company standard procedures
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Calculated based on plasma somapacitan activity measured in blood
| After the last dosing on Day 15 until Day 43 |
| Incidence of adverse events | Count | From first dosing to Day 43 |
| Occurrence of anti-somapacitan antibodies | Count | From Day 0 to Day 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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