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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001087-39 | EudraCT Number | ||
| U1111-1140-3741 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the influence of oral semaglutide (NNC0113-0217) on the pharmacokinetics of lisinopril and warfarin in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Victim and perpetrator compounds | Experimental | Subjects receive two different victim compounds (lisinopril and warfarin) and two different perpetrator compounds (placebo semaglutide with carrier and oral semaglutide). Each dosing occasion is separated by a 7-day wash-out period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | For oral administration once daily. Doses of 5 mg and 10 mg, respectively, will be given for 7 days followed by 20 mg administered on days 43-84. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the S-warfarin concentration-time curve | From dosing to infinity calculated from a 0-168 hours S-warfarin concentration-time-curve based on 18 sampling time points | |
| Area under the R-warfarin concentration-time curve | From dosing to infinity calculated from a 0-168 hours S-warfarin concentration-time-curve based on 18 sampling time points | |
| Area under the lisinopril concentration-time curve | From dosing to infinity calculated from a 0-60 hours lisinopril concentration-time-curve based on 13 sampling time points |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed S-warfarin plasma concentration | 0 to 168 hours after single dose | |
| Maximum observed R-warfarin plasma concentration | 0 to 168 hours after 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 |
|---|---|---|---|
| 30945118 | Background | Baekdal TA, Borregaard J, Hansen CW, Thomsen M, Anderson TW. Effect of Oral Semaglutide on the Pharmacokinetics of Lisinopril, Warfarin, Digoxin, and Metformin in Healthy Subjects. Clin Pharmacokinet. 2019 Sep;58(9):1193-1203. doi: 10.1007/s40262-019-00756-2. |
| 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 |
| D017706 | Lisinopril |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| lisinopril | Drug | For oral administration. A single dose of 20 mg is administered three times either alone or conconmitantly with a perpetrator compound (days 1, 15 and 71). |
|
| warfarin | Drug | For oral administration. A single dose of 5 mg is administered three times either alone or conconmitantly with a perpetrator compound (days 8, 22 and 78). |
|
| placebo | Drug | A single dose of SNAC is administered conconmitantly with victim compounds (days 15 and 22). |
|
| Maximum observed lisinopril plasma concentration |
| 0 to 60 hours after single dose |
| D015110 |
| 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |