Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sotrastaurin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| AEB071 300 mg | EXPERIMENTAL | - |
| AEB071 900 mg | EXPERIMENTAL | - |
| Placebo to AEB071 | PLACEBO_COMPARATOR | - |
| Moxifloxacin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| sotrastaurin | DRUG | - |
| placebo to sotrastaurin | DRUG | - |
| Avelox | DRUG | - |
Inclusion Criteria: * Healthy male and female subjects age 18 to 50 years (including both) of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Exclusion Criteria: * Smokers and tobacco ...
Sotrastaurin is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and remains in clinical development. The only completed trial evaluated its effect on the QT interval, a measure of heart rhythm, in healthy subjects.
Sotrastaurin is being developed by Novartis AG, which trades under the ticker NVS. The company sponsored a Phase 1 clinical trial of the drug in healthy volunteers in the United States.
Sotrastaurin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The single Phase 1 trial has been completed.
Sotrastaurin has one completed Phase 1 trial, identified as NCT01594255, titled "CAEB071 Thorough QTc Study in Healthy Volunteers." The trial enrolled 100 healthy participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, sotrastaurin is also known as CAEB071. The Phase 1 trial NCT01594255 uses the name CAEB071 in its title, confirming that both names refer to the same investigational drug.