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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001288-22 | EudraCT Number | ||
| U1111-1140-8551 | Other Identifier | WHO |
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The trial is conducted in Europe. The aim of the trial is to investigate the influence of semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single doses of atorvastatin and digoxin in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Administered as a subcutaneous injection (s.c., under the skin). Initiated with weekly semaglutide dosing of 0.25 mg in the first 4 weeks, 0.5 mg the next 4 weeks, and 1.0 mg in the third 4 week period. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the atorvastatin plasma concentration-time curve | From time 0 to 72 hours after a single dose | |
| Area under the digoxin plasma concentration-time curve | From time 0 to 120 hours after a single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed atorvastatin plasma concentration | From time 0 to 72 hours after a single dose | |
| Maximum observed digoxin plasma concentration | From time 0 to 120 hours after a single dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Berlin | 14050 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28349387 | Result | Hausner H, Derving Karsbol J, Holst AG, Jacobsen JB, Wagner FD, Golor G, Anderson TW. Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects. Clin Pharmacokinet. 2017 Nov;56(11):1391-1401. doi: 10.1007/s40262-017-0532-6. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| D004077 | Digoxin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| digoxin | Drug | Oral administration. Digoxin will be given as 2 single doses of 0.5 mg. |
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| atorvastatin | Drug | Oral administration. Atorvastatin will be given as 2 single doses of 40 mg. |
|
| Number of treatment emergent AEs (TEAEs) |
| From baseline (Visit 2, Day 1) to follow-up (Visit 12, 20 weeks after baseline) |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |