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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001255-19 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Norditropin® SimpleXx® 0.02 mg/kg + NNC126-0083 | Experimental |
| |
| Norditropin® SimpleXx® 0.04 mg/kg + NNC126-0083 | Experimental |
| |
| Norditropin® SimpleXx® 0.02 mg/kg + placebo | Placebo Comparator |
| |
| Norditropin® SimpleXx® 0.04 mg/kg + placebo | Placebo Comparator |
| |
| NNC126-0083 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC126-0083 | Drug | One of five dose levels administered subcutaneously (under the skin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | after administration of a single dose of NNC126-0083 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) (0-168h) after a single dose of NNC 126-0083 | 0-168 hours after trial drug administration | |
| Number of injection site reactions | after administration of a single dose of NNC126-0083 and after single dose of Norditropin® SimpleXx® |
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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 | Hvidovre | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20427496 | Result | Rasmussen MH, Bysted BV, Anderson TW, Klitgaard T, Madsen J. Pegylated long-acting human growth hormone is well-tolerated in healthy subjects and possesses a potential once-weekly pharmacokinetic and pharmacodynamic treatment profile. J Clin Endocrinol Metab. 2010 Jul;95(7):3411-7. doi: 10.1210/jc.2009-2813. Epub 2010 Apr 28. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Norditropin® SimpleXx® | Drug | One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin) |
|
| placebo | Drug | Placebo comparator |
|
| NNC126-0083 | Drug | One of three dose levels administered subcutaneously (under the skin) |
|
| Norditropin® SimpleXx® | Drug | One of two dose levels, followed by placebo, administered subcutaneously (under the skin) |
|
| IGF-I (Insulin-like Growth Factor I) levels | after ascending single doses of NNC126-0083 and a single dose of Norditropin® SimpleXx® |
| ID | Term |
|---|---|
| C558310 | NNC126-0083 |
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