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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1299-1093 | Other Identifier | World Health Organization (WHO) |
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The study is testing a new study drug in healthy normal weight Japanese and Caucasian participants after a single dose. The aim of this study is to see if the new medicine is safe and how it works in the participants body. Oral monlunabant is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The participant will either get monlunabant or placebo or a combination of both. Which treatment the participant get is decided by chance. The study will last for about 49 days in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monlunabant dose 1 | Experimental | Dose 1 of monlunabant treatment |
|
| Monlunabant dose 2 | Experimental | Dose 2 of monlunabant treatment |
|
| Monlunabant dose 3 | Experimental | Dose 3 of the monlunabant treatment |
|
| Placebo (monlunabant) | Placebo Comparator | Placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monlunabant | Drug | Oral monlunabant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant | Number of events | From dosing (day 1) to end of study visit (day 21) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞,monlunabant, SD; the area under the monlunabant plasma concentration-time curve from time 0 to infinity after single dose of oral monlunabant | h*nmol/L | From pre-dose (day 1) to end of study visit (day 21) |
| Cmax, monlunabant, SD; the maximum plasma concentration of monlunabant after single dose of oral monlunabant |
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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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Sponsor staff involved in the clinical trial is masked according to company standard procedures
| Placebo (monlunabant) | Drug | Oral placebo (monlunabant) |
|
nmol/L |
| From pre-dose (day 1) to end of study visit (day 21) |
| tmax,monlunabant, SD; the time of maximum observed plasma concentration of monlunabant single dose of oral monlunabant | h (hours) | From pre-dose (day 1) to end of study visit (day 21) |
| t½,monlunabant,SD; the terminal half-life of monlunabant after single dose of oral monlunabant | h (hours) | From pre-dose (day 1) to end of study visit (day 21) |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| 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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