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This study has been designed in compliance with the ICH-E14 guideline 2005 to evaluate the QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AEB071 300 mg | Experimental |
| |
| AEB071 900 mg | Experimental |
| |
| Placebo to AEB071 | Placebo Comparator |
| |
| Moxifloxacin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sotrastaurin | Drug |
| ||
| sotrastaurin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the corrected QT interval (QTc) in healthy volunteers as compared to placebo. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in concentration of exposure-response AEB071 and AEE800 (a metabolite of AEB071) concentrations compared to cardiac repolarization intervals | 24 hours | |
| Tolerability of 300 and 900 mg of AEB071. | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigational Site | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| C543528 | sotrastaurin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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|
| placebo to sotrastaurin | Drug |
|
| Avelox | Drug |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |