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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1267-4230 | Other Identifier | World Health Organization (WHO) |
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This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0194-0499 12 mg | Experimental | Participants will receive a single subcutaneous (s.c.) dose of 12 milligrams (mg) NNC0194-0499 on Day 1. |
|
| NNC0194-0499 30 mg | Experimental | Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1. |
|
| NNC0194-0499 96 mg | Experimental | Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0194-0499 | Drug | Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose | Measured in nanomoles*hours per liter (nmol h/L). | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose | Measured in nmol h/L. | From Day 1 (pre-dose) until Day 7 (168 hours) |
| Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan Central Hospital | Jinan | Shandong | 250062 | China |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| NNC0194-0499 | Drug | Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1. |
|
| NC0194-0499 | Drug | Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1. |
|
Measured in nmol/L. |
| From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |
| tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499 | Measured in hours. | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |
| t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499 | Measured in hours. | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |
| CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499 | Measured in liters per hour (L/h). | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |
| Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase | Measured in liters (L). | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |
| Relative change in triglycerides | Measured in Percent change. | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |
| Relative change in high-density lipoprotein (HDL) cholesterol | Measured in Percent change. | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |
| Relative change in low-density lipoprotein (LDL) cholesterol | Measured in Percent change. | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |