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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1253-4467 | Other Identifier | World Health Organization (WHO) |
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Participants in the study, will receive the study drug once daily for 10 days in tablet form for oral (by mouth) intake. On day 1 to 5 the tablet will contain 3 mg semaglutide, and on day 6-10 the tablet will contain 7 mg semaglutide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral semaglutide | Experimental | All participants will receive oral semaglutide once daily for a total of 10 days: 3 mg for 5 days followed by 7 mg for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral semaglutide | Drug | Oral semaglutide once daily for a total of 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the semaglutide milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,milk) | nmol*h/L | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the salcaprozate sodium (SNAC) milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,milk) | ng*h/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Average semaglutide milk concentration during a dosing interval after the 10th dosing (Cavg,sema,D10,milk) | nmol/L | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum semaglutide milk concentration during a dosing interval after the 10th dosing (Cmax,sema,D10,milk) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Services, LLC | San Antonio | Texas | 78209 | United States | ||
| ICON-Salt Lake City |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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nmol/L |
| From 0 to 24 hours after the 10th dosing (day 10) |
| Minimum semaglutide milk concentration during a dosing interval after the 10th dosing (Cmin,sema,D10,milk) | nmol/L | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum semaglutide milk concentration during a dosing interval after the 10th dosing (tmax,sema,D10,milk) | Hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Estimated daily infant semaglutide dose | mg/kg/day | From 0 to 24 hours after the 10th dosing (day 10) |
| Relative daily infant semaglutide dose | From 0 to 24 hours after the 10th dosing (day 10) |
| Average SNAC milk concentration during a dosing interval after the 10th dosing (Cavg,SNAC,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum SNAC milk concentration during a dosing interval after the 10th dosing (Cmax,SNAC,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Minimum SNAC milk concentration during a dosing interval after the 10th dosing (Cmin,SNAC,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum SNAC milk concentration during a dosing interval after the 10th dosing (tmax,SNAC,D10,milk) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Estimated daily infant SNAC dose | ng/kg/day | From 0 to 24 hours after the 10th dosing (day 10) |
| Relative daily infant SNAC dose | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the SNAC metabolite E494 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E494,D10,milk) | ng*h/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Average SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cavg,E494,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cmax,E494,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Minimum SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cmin,E494,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum SNAC metabolite E494 milk concentration after the 10th dosing (tmax,E494,D10,milk) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Estimated daily infant SNAC metabolite E494 dose | ng/kg/day | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the SNAC metabolite E506 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E506,D10,milk) | ng*h/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Average SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cavg,E506,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cmax,E506,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Minimum SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cmin,E506,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum SNAC metabolite E506 milk concentration after the 10th dosing (tmax,E506,D10,milk) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Estimated daily infant SNAC metabolite E506 dose | ng/kg/day | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the SNAC metabolite E1245 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,milk) | ng*h/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Average SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cavg,E1245,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cmax,E1245,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Minimum SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cmin,E1245,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum SNAC metabolite E1245 milk concentration after the 10th dosing (tmax,E1245,D10,milk) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Estimated daily infant SNAC metabolite E1245 dose | ng/kg/day | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the SNAC metabolite E1246 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1246,D10,milk) | ng*h/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Average SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cavg,E1246,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cmax,E1246,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Minimum SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cmin,E1246,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum SNAC metabolite E1246 milk concentration in milk after the 10th dosing (tmax,E1246,D10,milk) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Estimated daily infant SNAC metabolite E1246 dose | ng/kg/day | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the SNAC metabolite E1247 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1247,D10,milk) | ng*h/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Average SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cavg,E1247,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cmax,E1247,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Minimum SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cmin,E1247,D10,milk) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum SNAC metabolite E1247 milk concentration after the 10th dosing (tmax,E1247,D10,milk) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Estimated daily infant SNAC metabolite E1247 dose | ng/kg/day | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the semaglutide plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,plasma) | nmol*h/L | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum semaglutide plasma concentration during a dosing interval after the 10th dosing (Cmax,sema,D10,plasma) | nmol/L | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum semaglutide plasma concentration during a dosing interval after the 10th dosing (tmax,sema,D10,plasma) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the SNAC plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,plasma) | ng*h/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum SNAC plasma concentration during a dosing interval after the 10th dosing (Cmax,SNAC,D10,plasma) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum SNAC plasma concentration during a dosing interval after the 10th dosing (tmax,SNAC,D10,plasma) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the SNAC metabolite E494 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E494,D10,plasma) | ng*h/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum SNAC metabolite E494 plasma concentration during a dosing interval after the 10th dosing (Cmax,E494,D10,plasma) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum SNAC metabolite E494 plasma concentration during a dosing interval after the 10th dosing (tmax,E494,D10,plasma) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the SNAC metabolite E506 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E506,D10,plasma) | ng*h/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum SNAC metabolite E506 plasma concentration during a dosing interval after the 10th dosing (Cmax,E506,D10,plasma) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum SNAC metabolite E506 plasma concentration during a dosing interval after the 10th dosing (tmax,E506,D10,plasma) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the SNAC metabolite E1245 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,plasma) | ng*h/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum SNAC metabolite E1245 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1245,D10,plasma) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum SNAC metabolite E1245 plasma concentration during a dosing interval after the 10th dosing (tmax,E1245,D10,plasma) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the SNAC metabolite E1246 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1246,D10,plasma) | ng*h/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum SNAC metabolite E1246 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1246,D10,plasma) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum SNAC metabolite E1246 plasma concentration during a dosing interval after the 10th dosing (tmax,E1246,D10,plasma) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Area under the SNAC metabolite E1247 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1247,D10,plasma) | ng*h/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Maximum SNAC metabolite E1247 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1247,D10,plasma) | ng/mL | From 0 to 24 hours after the 10th dosing (day 10) |
| Time to maximum SNAC metabolite E1247 plasma concentration during a dosing interval after the 10th dosing (tmax,E1247,D10,plasma) | hours | From 0 to 24 hours after the 10th dosing (day 10) |
| Salt Lake City |
| Utah |
| 84124 |
| United States |
| D004700 | Endocrine System Diseases |