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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-0672 | Other Identifier | World Health Organization (WHO) | |
| 2021-001452-34 | EudraCT Number |
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In this study, four new tablet versions of two compounds will be investigated.
The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance.
Participants will receive one treatment for 10 days in the first period. For the second period, directly following, participants will receive a different treatment for five more days.
The study can last for up to approximately 10 weeks for each participant. This includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Oral semaglutide | Experimental | Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days |
|
| Part B: NNC0385-0434 | Experimental | Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide D | Drug | Tablet given orally |
| |
| Semaglutide G |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose | h * nmol/L | From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose | nmol/L | From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration |
| tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API |
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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 |
|---|---|---|---|---|---|---|
| Altasciences Company Inc. | Montreal | Quebec | H3P 3P1 | Canada | ||
| Parexel International GmbH |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| Drug |
Tablet given orally |
|
| Semaglutide H | Drug | Tablet given orally |
|
| Semaglutide I | Drug | Tablet given orally |
|
| NNC0385-0434 B | Drug | Tablet given orally |
|
| NNC0385-0434 C | Drug | Tablet given orally |
|
| NNC0385-0434 D | Drug | Tablet given orally |
|
| NNC0385-0434 E | Drug | Tablet given orally |
|
hours |
| From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration |
| Berlin |
| 14050 |
| Germany |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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