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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1119-1560 | Other Identifier | WHO | |
| 2011-000297-57 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC 0113-0987 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC 0113-0987 (gastro) | Experimental |
| |
| NNC 0113-987 (coated) | Experimental |
| |
| NNC 0113-987 (i.v) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral NNC 0113-0987 | Drug | Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Overview of Treatment Emergent Adverse Events (AEs) | Up to 25 days after trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of hypoglycaemic episodes | From screening (day 1-21 before trial product administration) and until completion of the post treatment follow-up visit (day 12-25 after trial product administration) | |
| AUC0-240h; area under the NNC 0113-0987 concentration-time curve |
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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 |
|---|---|---|---|---|---|---|
| Nottingham | NG11 6JS | United Kingdom |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| oral NNC 0113-0987 | Drug | Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation. |
|
| I.v. NNC 0113-0987 | Drug | Subjects will be administered a single i.v (into the vein) dose. The treatment with NNC 0113-0987 will be open-label, and will not be randomised. |
|
| oral placebo | Drug | Subjects will be randomised to receive a single dose of placebo. |
|
| From time 0 to 240 hours after a single oral or intravenous (i.v.) dose |
| AUC, area under the curve | From time 0 to infinity after a single oral or i.v. dose |
| Cmax; maximum concentration of NNC 0113-0987 in plasma | After a single oral or i.v. dose |
| The time to maximum concentration (tmax) of NNC 0113-0987 in plasma | After a single oral dose |