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| Name | Class |
|---|---|
| Pierre and Marie Curie University | OTHER |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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The study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples.
An ECG is performed after a dose of sotalol on about 100 healthy subjects in order to identify about 20 extreme responders (10 high responders and 10 non responders) assessed as Delta QTcf compare to baseline. The ECG will be measured and the delta QTcf will be calculated on the 20 selected subjects in a second part of the clinical trial, cross over erythromycin/placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythromycin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythromycin | Drug | 4mg/Kg, IV during 20 min once |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Prolongation of cardiac QT due to erythromycin compare to Placebo reported as Delta QTcf | Delta QTcf is measured at H0, H0+20 minutes, and H0+1h20, on groups' erythromycin and placebo. QTcf may be adjusted based on the pharmacokinetic data to ensure time of the plasmatic pick is used. | 1hour and 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison Delta QTcf eryhtromycin-sotalol | compare the effect of erythromycin and sotalol on QT prologation | over 3 hours |
| Assess the effect of erythromycin Twave morphologie changes | Analysis of Qwave morphologic changes |
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Inclusion Criteria:
Non Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Sebastien Hulot, MD | University PMCurrie-INSERM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIOTRIAL | Rueil-Malmaison | 92500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28134617 | Derived | Stillitano F, Hansen J, Kong CW, Karakikes I, Funck-Brentano C, Geng L, Scott S, Reynier S, Wu M, Valogne Y, Desseaux C, Salem JE, Jeziorowska D, Zahr N, Li R, Iyengar R, Hajjar RJ, Hulot JS. Modeling susceptibility to drug-induced long QT with a panel of subject-specific induced pluripotent stem cells. Elife. 2017 Jan 30;6:e19406. doi: 10.7554/eLife.19406. |
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| ID | Term |
|---|---|
| D004917 | Erythromycin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Drug |
4mg/Kg, IV during 20 min once |
|
| 1hour and 20 min |