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| ID | Type | Description | Link |
|---|---|---|---|
| Universal Trial Number | Other Identifier | U1111-1315-2873 |
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The purpose of this study is to test a new medicine called Inno8. The study will test how eating and drinking before and after taking Inno8 affects how well it is absorbed in the stomach. The study consists of four arms. Participants will take the study medicine after an overnight fast. How long participants will need to fast depends on which group participants are in. After taking the study medicine, participants will need to fast again. The study will last for up to 9.5 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants will receive oral dose of NNC0442-0344 A. |
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| Group B | Experimental | Participants will receive oral dose of NNC0442-0344 A. |
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| Group C | Experimental | Participants will receive oral dose of NNC0442-0344 A. |
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| Reference dose | Active Comparator | Participants will receive oral dose of NNC0442-0344 A. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0442-0344 A | Drug | NNC0442-0344 A will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞: the area under the plasma Inno8 concentration-time curve from time 0 to infinity after a single oral dose | Measured as nanograms*day per millilitre (ng*day/mL). | From baseline (Day 1) to day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum observed plasma Inno8 concentration after a single oral dose | Measured as nanograms per millilitre (ng/mL). | From baseline (Day 1) to day 17 |
| Tmax: The time to maximum observed plasma Inno8 concentration after a single oral dose |
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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 Clinical LA, Inc. | Cypress | California | 90630 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Measured as hours.
| From baseline (Day 1) to day 17 |
| Number of treatment emergent adverse events | Measured as count of events. | From time of dosing (Day 1) to day 36 |
| Change in D-dimer | Measured as absolute (ng/mL) and percentage (%). | From baseline (Day 1) to day 36 |
| Change in prothrombin fragment 1 and 2 | Measured as absolute [(picomoles per litre) pmol/L] and %. | From baseline (Day 1) to day 36 |
| Change in fibrinogen | Measured as absolute [(milligrams per decilitre) mg/dL] and %. | From baseline (Day 1) to day 36 |
| Change in platelets | Measured as absolute [(ten to the ninth power per litre) 10^9/L] and %. | From baseline (Day 1) to day 36 |
| Change in FIX antigen | Measured as %. | From baseline (Day 1) to day 36 |
| Change in FX antigen | Measured as %. | From baseline (Day 1) to day 36 |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |