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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001821-14 | EudraCT Number |
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The purpose of this study is to assess the effect of a single therapeutic dose and a single supra-therapeutic dose of imeglimin on the QT/QTc interval
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imeglimin therapeutic dose | Experimental | Tablet, oral, single dose |
|
| Imeglimin supratherapeutic dose | Experimental | Tablet, oral, single dose |
|
| Placebo | Placebo Comparator | Tablet, oral, single dose |
|
| Moxifloxacin | Active Comparator | Tablet, oral, single dose (400 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| Imeglimin |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QTcF (deltaQTcF) | Up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Dubourg, MD | Poxel SA | Study Director |
| Pascale Fouqueray, MD, PhD | Poxel SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research (HMR) | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32556539 | Derived | Dubourg J, Perrimond-Dauchy S, Felices M, Bolze S, Voiriot P, Fouqueray P. Absence of QTc prolongation in a thorough QT study with imeglimin, a first in class oral agent for type 2 diabetes mellitus. Eur J Clin Pharmacol. 2020 Oct;76(10):1393-1400. doi: 10.1007/s00228-020-02929-6. Epub 2020 Jun 18. |
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| ID | Term |
|---|---|
| C575881 | imeglimin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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|
| Moxifloxacin | Drug |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |