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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000550-21 | EudraCT Number | ||
| U1111-1139-1272 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic impairment compared to subjects with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with hepatic impairment | Experimental |
| |
| Subjects with normal hepatic function | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the semaglutide plasma concentration curve | From time 0 to 24 hours after the 10th dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed semaglutide plasma concentration | 0 to 24 hours after the 10th dosing | |
| Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve | From time 0 to 24 hours after the 10th dosing |
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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 | Prague | 10034 | Czechia | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29693715 | Result | Baekdal TA, Thomsen M, Kupcova V, Hansen CW, Anderson TW. Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment. J Clin Pharmacol. 2018 Oct;58(10):1314-1323. doi: 10.1002/jcph.1131. Epub 2018 Apr 25. | |
| 33969456 | Derived | Overgaard RV, Navarria A, Ingwersen SH, Baekdal TA, Kildemoes RJ. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials. Clin Pharmacokinet. 2021 Oct;60(10):1335-1348. doi: 10.1007/s40262-021-01025-x. Epub 2021 May 10. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| 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 |
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| Maximum observed SNAC plasma concentration | 0 to 24 hours after the 10th dosing |
| Prague |
| 17000 |
| Czechia |
| Novo Nordisk Investigational Site | Bialystok | 15-879 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 02-507 | Poland |
| Novo Nordisk Investigational Site | WoĊomin | 05-200 | Poland |
| Novo Nordisk Investigational Site | Bratislava | 83101 | Slovakia |