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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001578-33 | EudraCT Number |
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This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
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| B | Experimental |
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| C | Experimental |
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| D | Experimental |
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| E | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC126-0083 | Drug | Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (adverse events, local tolerability, physical examination) | 0 to 10 days after third dosing, (day 15-25 after first dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, maximum concentration of IGF-I | 7 days after first dosing and 10 days after the third dosing (day 1-25 after first dose) |
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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 |
|---|---|---|---|
| 20718773 | Result | Rasmussen MH, Jensen L, Anderson TW, Klitgaard T, Madsen J. Multiple doses of pegylated long-acting growth hormone are well tolerated in healthy male volunteers and possess a potential once-weekly treatment profile. Clin Endocrinol (Oxf). 2010 Dec;73(6):769-76. doi: 10.1111/j.1365-2265.2010.03863.x. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| NNC126-0083 | Drug | Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks |
|
| NNC126-0083 | Drug | Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks |
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| NNC126-0083 | Drug | Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks |
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| placebo | Drug | Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks |
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| placebo | Drug | Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks |
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| placebo | Drug | Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks |
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| placebo | Drug | Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks |
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| NNC126-0083 | Drug | Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks |
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| placebo | Drug | Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks |
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| ID | Term |
|---|---|
| C558310 | NNC126-0083 |
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