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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1332-5554 | Other Identifier | World Health Organization (WHO) |
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The purpose of this clinical study is to find out if UBT251 is safe and effective to be taken together with medicines, like midazolam, caffeine and warfarin in participants living with overweight or obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UBT251 | Experimental | UBT251 will be administered subcutaneously with gradual dose escalation during the study. |
|
| Cocktail (Warfarin/Caffeine/Midazolam) | Experimental | A cocktail containing warfarin, caffeine, and midazolam will be administered at predefined study visits to evaluate the effect of UBT251 on the pharmacokinetics of CYP enzyme substrates. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UBT251 | Drug | Administered subcutaneously. |
| |
| Cocktail (Warfarin/Caffeine/Midazolam) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,s-warfarin: The area under the plasma s-warfarin concentration-time curve extrapolated to infinity after single dose | Measured in nanogram hour per millilitre (ng*h/mL). | From pre-dose on Day 1 up to 156 days |
| AUC0-∞,caffeine : The area under the plasma caffeine concentration-time curve extrapolated to infinity after single dose | Measured in ng*h/mL. | From pre-dose on Day 1 up to 156 days |
| AUC0-∞,midazolam: The area under the midazolam concentration-time curve extrapolated to infinity after single dose | Measured in ng*h/mL. | From pre-dose on Day 1 up to 156 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,s-warfarin: The maximum observed plasma s-warfarin concentration after single dose | Measured in nanogram per millilitre (ng/mL). | From pre-dose on Day 1 up to 156 days |
| Cmax,caffeine: The maximum observed plasma caffeine concentration after single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| 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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| Drug |
Administered orally. |
|
Measured in ng/mL. |
| From pre-dose on Day 1 up to 156 days |
| Cmax,midazolam: The maximum observed plasma midazolam concentration after single dose | Measured in ng/mL. | From pre-dose on Day 1 up to 156 days |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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