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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002418-54 | EudraCT Number | ||
| U1111-1170-7054 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to evaluate the effect of SNAC on cardiac repolarisation in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, SNAC | Experimental | Single dose of 1.2mg, 2.4mg or 3.6mg increasing for each cohort of trial participants. |
|
| Part A, placebo | Placebo Comparator | Single dose at corresponding dose levels. |
|
| Part B, SNAC, Placebo, Moxifloxacin | Experimental | Subjects will receive 4 different treatments in random order. SNAC dose between 1.2-3.6 mg, Placebo in two different periods, moxifloxacin 400mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNAC | Drug | Oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | PART A | From dosing (day 1) to follow-up (days 8-11) |
| The co-primary endpoints are Fridericia heart rate corrected QT interval (QTcF) | PART B | At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8, and 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed SNAC plasma concentration | PART A | From 0 to 12 hours |
| Trial population-specific (accounted for individual subject levels) corrected QT interval (QTcP) | PART B |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Berlin | 14050 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34319564 | Derived | Granhall C, Baekdal TA, Breitschaft A, Sondergaard FL, Anderson TW, Thomsen M. Absence of QTc Prolongation with Sodium N-(8-[2-Hydroxybenzoyl] Amino) Caprylate (SNAC), an Absorption Enhancer Co-Formulated with the GLP-1 Analogue Semaglutide for Oral Administration. Diabetes Ther. 2021 Sep;12(9):2599-2610. doi: 10.1007/s13300-021-01106-x. Epub 2021 Jul 28. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo |
| Drug |
Oral administration |
|
| Moxifloxacin | Drug | Oral administration |
|
| At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8 and 12 hours |
| Area under the SNAC plasma concentration time curve | PART B | From 0 to 12 hours |
| Maximum observed SNAC plasma concentration | PART B | From 0 to 12 hours |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |