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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1304-9627 | Other Identifier | World Health Organisation (WHO) |
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This study is conducted to compare four different tablets containing the investigational medicine semaglutide at the same dose. It is done to test how semaglutide in each of the tablet versions is taken up in the body. Which treatments participants will receive is decided by chance. The study will last for about 28 weeks. The study will enroll healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Semaglutide J then Semaglutide L | Experimental | Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide L in treatment period 2. |
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| Sequence 2: Semaglutide L then Semaglutide J | Experimental | Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide L then semaglutide J in treatment period 2. |
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| Sequence 3: Semaglutide J then Semaglutide M | Experimental | Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide M in treatment period 2. |
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| Sequence 4: Semaglutide M then Semaglutide J | Experimental | Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide M then semaglutide J in treatment period 2. |
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| Sequence 5: Semaglutide J then Semaglutide N |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide B | Drug | Semaglutide B will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve | Measured in hours nanomoles per liter (h * nmol/L). | From 0 to 24 hours after dosing on Days 122 and 132. |
| Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration | Measured in nanomoles per liter(nmol/L). | From 0 to 24 hours after dosing on Days 122 and 132. |
| Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration | Measured in hours. | From 0 to 24 hours after dosing on Days 122 and 132. |
| t½,sema; the terminal half-life of semaglutide | Measured in hours. | From 0 to 840 hours after dosing on Day 132. |
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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 | Montreal | Quebec | H3P 3P1 | Canada |
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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| Experimental |
Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide J then semaglutide N in treatment period 2. |
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| Sequence 6: Semaglutide N then Semaglutide J | Experimental | Participants will receive subcutaneously semagutide B in treatment period 1 followed by oral semaglutide N then semaglutide J in treatment period 2. |
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| Semaglutide J | Drug | Semaglutide J will be administered as oral tablets. |
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| Semaglutide L | Drug | Semaglutide L will be administered as oral tablets. |
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| Semaglutide M | Drug | Semaglutide M will be administered as oral tablets. |
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| Semaglutide N | Drug | Semaglutide N will be administered as oral tablets. |
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