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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1209-3837 | Other Identifier | World Health Organization (WHO) |
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The aim of this study is to assess how safe the study drug is and how well a participant tolerates it after a single oral (taken by mouth) dose. The study also aims to measure the concentration of the study drug and its breakdown products after a single dose. Participants will either get NNC0113-2023 (a new medicine) or placebo (a "dummy medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get one dose (can be one or two tablets) of study medicine. The study will last for about 65 days. Participants will have 10 scheduled site visits with the study physician or study staff at the study centre. For one of the visits, participants will stay at the research unit for 5 days. At all visits, except the first information visit, participants will have blood drawn along with other clinical assessments. Participants cannot take part in this study if participants have any disorder that the doctor thinks is a health problem. Only healthy men are allowed to take part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0113-2023 | Experimental | Participants will receive increasing doses of NNC0113-2023 on day 1. Each participant will receive only a single dose. |
|
| Placebo | Placebo Comparator | Participants will receive placebo (NNC0113-2023) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0113-2023 | Drug | Participants will receive dose levels of 1 mg, 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of NNC0113-2023 orally. Each participant will receive only one dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Count of events | From time of dosing (day 1) until completion of the follow-up visit (day 43) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,2023,SD; the area under the NNC0113-2023 plasma concentration-time curve from time 0 to infinity after a single dose of oral NNC0113-2023 | Measured in nmol/L*h | From baseline (day 1) to post treatment follow-up (day 43) |
| Cmax,2023,SD; the maximum plasma concentration of NNC0113-2023 after a single dose of oral NNC0113-2023 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | San Antonio | Texas | 78209 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo (NNC0113-2023) | Drug | Participants will receive NNC0174-0833 matched placebo orally. |
|
Measured in nmol/L |
| From baseline (day 1) to post treatment follow-up (day 43) |
| AUC0-24h,SNAC,SD; the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after a single dose of oral NNC0113-2023 | Measured in ng/mL*h | From baseline (day 1) to 24 hours after dosing |
| Cmax,SNAC,SD; the maximum plasma concentration of SNAC in plasma after a single dose of oral NNC0113-2023 | Measured in ng/mL | From baseline (day 1) to 24 hours after dosing |
| D004700 | Endocrine System Diseases |