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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001835-10 | EudraCT Number | ||
| U1111-1278-1745 | Other Identifier | World Health Organization (WHO) |
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The study medicine NNC0194-0499 is under development for non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH). All participants will receive a single dose of 30 milligram (mg) of the study medicine. The study medicine will be given in the form of an injection of 0.6 millilitres in a skinfold of the thigh (subcutaneous). The study will last for up to 64 days. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Women who are able to become pregnant must use highly effective contraception and will be counselled on the use of contraception. Participants with impaired liver function will undergo an ultrasound of the belly and measurement of brain activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive a single subcutaneous dose of 30 milligram (mg) of NNC0194-0499 on Day 1. |
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| Participants With Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment (Child Pugh Grade A) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1. |
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| Participants With Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment (Child-Pugh Grade B) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1. |
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| Participants With Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment (Child-Pugh Grade C) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0194-0499 | Drug | NNC0194-0499 will be administered subcutaneously in a skinfold in the thigh in the form of a solution for injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞, Single Dose, NNC0194-0499: the area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose | Measured in nanomoles hour per liter (nmol h/L). | From 0 hours (Day 1) until end of study visit (Day 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, NNC0194-0499: the maximum concentration of NNC0194-0499 in serum | Measured in nanomoles per liter (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 |
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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 |
|---|---|---|---|---|---|---|
| APEX Research | München | 81241 | Germany | |||
| Uniwersyteckie Centrum Kliniczne (UCK) |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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 in serum | Measured in hours. | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |
| CL/F, NNC0194-0499: the apparent total serum clearance of NNC0194-0499 | Measured in liters per hour. | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |
| Vz/F, NNC0194-0499: apparent volume of distribution of NNC0194-0499 after a single dose | Measured in liters. | From Day 1 (pre-dose) until completion of the end of trial visit (Day 36) |
| Number of treatment emergent adverse events (TEAEs) | Measured as number of events. | From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 8, Day 36) |
| Gdansk |
| 80-214 |
| Poland |
| Cardiomedicum Sp. z o.o. | Krakow | 30-002 | Poland |
| Summit Clinical Research s.r.o. | Bratislava | 83101 | Slovakia |
| Summit Clinical Research s.r.o. | Malacky | 901 22 | Slovakia |