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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005073-31 | EudraCT Number | ||
| U1111-1136-6455 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to evaluate the effect of semaglutide on cardiac repolarisation in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: semaglutide + moxifloxacin placebo | Experimental | Subjects will receive a single dose of moxifloxacin placebo both before the start of semaglutide treatment and at the end of the semaglutide treatment. |
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| Arm 2A: | Active Comparator | Semaglutide placebo + moxifloxacin/moxifloxacin placebo: Subjects will receive moxifloxacin before the start of semaglutide placebo treatment and moxifloxacin placebo at the end of the semaglutide placebo treatment. |
|
| Arm 2B: | Experimental | Semaglutide placebo + moxifloxacin placebo/moxifloxacin: Subjects will receive moxifloxacin placebo before the start of semaglutide placebo treatment and moxifloxacin at the end of the semaglutide placebo treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Solution for subcutaneous (s.c., under the skin) injection. Dose escalation to 1.5 mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| QTcI, (Individual heart rate corrected QT (Interval in the ECG: from the start of the QRS complex to the end) interval) based on ECG recordings obtained at 11 time points | 0-48 hours after the fourth dose of semaglutide/semaglutide placebo at the 1.5 mg dose level |
| Measure | Description | Time Frame |
|---|---|---|
| QTcI, based on ECG (electrocardiogram) recordings obtained at 2 out of 8 time points | 0-24 hours after a single dose of moxifloxacin/moxifloxacin placebo |
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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 |
|---|---|---|---|
| 29799100 | Result | Demmel V, Sandberg-Schaal A, Jacobsen JB, Golor G, Pettersson J, Flint A. No QTc Prolongation with Semaglutide: A Thorough QT Study in Healthy Subjects. Diabetes Ther. 2018 Aug;9(4):1441-1456. doi: 10.1007/s13300-018-0442-0. Epub 2018 May 24. |
| 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 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| placebo | Drug | Solution for s.c. injection or tablets for oral administration |
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| moxifloxacin | Drug | Tablets for oral administration |
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |