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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1232-7100 Trial | Other Identifier | World Health Organization (WHO) |
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The study looks at how the study medicine (NNC9204-1177) affects other medicines in the body. Participants will get the study medicine and 5 other medicines which have all been approved by the authorities. Participants will get 1 injection of the study medicine each week for 11 weeks. The study medicine is injected under the skin in the stomach area. All injections will be given by study staff. Participants will get 5 medicines as tablets, capsules or syrup to be taken with water at the beginning of the study and after 10 weeks of treatment with the study medicine. The study will last for about 4 months. Participants will have 14 visits to the clinic with the study staff and study doctor. Participants will have blood draws and 2 different kinds of electrocardiograms taken during the study. They will be asked about your mental health. People who use any medication, including herbal products, cannot take part in the study. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period or if they use birth control pills or other hormonal birth control products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC9204-1177 and cocktail of approved drugs | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC9204-1177 | Drug | Increasing doses of NNC9204-1177 administered s.c. (subcutaneously, under the skin) in the stomach area once-weekly for 11 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve extrapolated to infinity of the caffeine | ng*h/mL | From 0 to 24 hours after a single dose of caffeine without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) |
| Area under the plasma concentration-time curve extrapolated to infinity of the omeprazole | ng*h/mL | From 0 to 8 hours after a single dose of omeprazole without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) |
| Area under the plasma concentration-time curve extrapolated to infinity of the midazolam | ng*h/mL | From 0 to 12 hours after a single dose of midazolam without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) |
| Area under the plasma concentration-time curve extrapolated to infinity of the s-warfarin | ng*h/mL | From 0 to 168 hours after a single dose of warfarin without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) |
| Area under the plasma concentration-time curve extrapolated to infinity of the dextromethorphan | ng*h/mL | From 0 to 72 hours after a single dose of dextromethorphan without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma caffeine concentration after a single dose | ng/mL | From 0 to 24 hours after a single dose of caffeine without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) |
| Maximum observed plasma omeprazole concentration after a single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | San Antonio | Texas | 78209 | United States |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Single-sequence, cross-over drug interaction trial
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| Cocktail of 5 already approved drugs | Drug | 5 medicines as tablets, capsules or syrup to be taken with water on Day 1 and Day 78 of the study |
|
ng/mL |
| From 0 to 8 hours after a single dose of omeprazole without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) |
| Maximum observed plasma s-warfarin concentration after a single dose | ng/mL | From 0 to 168 hours after a single dose of warfarin without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) |
| Maximum observed plasma midazolam concentration after a single dose | ng/mL | From 0 to 12 hours after a single dose of midazolam without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) |
| Maximum observed plasma dextromethorphan concentration after a single dose | ng/mL | From 0 to 72 hours after a single dose of dextromethorphan without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| 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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