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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1271-3953 | Other Identifier | World Health Organization (WHO) |
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In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2). |
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| Sequence 2 | Experimental | Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2). |
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| Sequence 3 | Experimental | Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2). |
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| Sequence 4 | Experimental | Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2). |
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| Sequence 5 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0385-0434 G | Drug | Participants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2). |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval | Measured in h * nmol/L | From 0 to 24 hours after dose administration on visit 2, day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434 | Measured in nmol/L | From 0 to 24 hours after dose administration on visit 2, day 10 |
| tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434 |
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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 |
|---|---|---|---|---|---|---|
| Altasciences | Cypress | California | 90630 | United States | ||
| Altasciences Clinical Los Angeles, Inc. |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).
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| Sequence 6 | Experimental | Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2). |
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| NNC0385-0434 F | Drug | Participants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2). |
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| NNC0385-0434 B | Drug | Participants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2). |
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Measured in hours |
| From 0 to 24 hours after dose administration on visit 2, day 10 |
| Los Angeles |
| California |
| 90630 |
| United States |
| D009750 |
| Nutritional and Metabolic Diseases |