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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000047-27 | EudraCT Number | ||
| U1111-1126-7584 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC0113-0987 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0113-0987 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0113-0987 | Drug | A single dose for oral administration, up to 7 dose levels will be investigated. If a non-tolerated dose level has been reached, the dose level will not be increased further. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25) |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of hypoglycaemic episodes | From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25) | |
| AUC, the area under the NNC0113-0987 plasma concentration-time curve | From dosing visit to infinity |
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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 | 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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| placebo | Drug | A single dose of oral placebo administered. |
|
| Cmax, the maximum plasma concentration of NNC0113-0987 | From dosing visit until last PK sampling visit (e.g. day 11) |
| tmax, the time to maximum plasma concentration of NNC0113-0987 | From dosing visit until last PK sampling visit (e.g. day 11) |