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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000188-10 | EudraCT Number | ||
| U1111-1138-4595 | 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 multiple doses of NNC0113-0987 in an oral formulation in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral B (DC) | Experimental | Escalation design. Planned end dose level is 5 mg alternative dosing condition (fasting for 30 minutes post-dosing) |
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| Oral D | Experimental | Escalation design. Planned end dose level is 20 mg standard dosing condition (fasting for 120 minutes post-dosing) |
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| Oral C | Experimental | Escalation design. Planned end dose level is 10 mg standard dosing condition (fasting for 120 minutes post-dosing) |
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| Oral B | Experimental | Escalation design. Planned end dose level is 5 mg standard dosing condition (fasting for 120 minutes post-dosing) |
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| Oral A | Experimental | Escalation design. Planned end dose level is 2.5 mg standard dosing condition (fasting for 120 minutes post-dosing) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0113-0987 | Drug | Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events recorded | From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hypoglycaemic episodes | From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97) | |
| Area under the NNC0113-0987 plasma concentration time curve | During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69) |
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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 |
|---|---|---|---|---|---|---|
| Berlin | 14050 | Germany |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| placebo | Drug | Tablets for one-daily oral administration. |
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| Maximum observed NNC0113-0987 plasma concentration | During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69) |