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sotrastaurin

Phase 1

Healthy | Small molecule | Other |Novartis AG|Last Updated: May 9, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01594255CAEB071 Thorough QTc Study in Healthy VolunteersPHASE1 COMPLETED 100Jul 1, 2009 -May 9, 20121 United States
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Study Endpoints
Primary Endpoints
Change in the corrected QT interval (QTc) in healthy volunteers as compared to placebo.
24 hours
Secondary Endpoints
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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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AEB071 300 mgEXPERIMENTAL -
AEB071 900 mgEXPERIMENTAL -
Placebo to AEB071PLACEBO_COMPARATOR -
MoxifloxacinACTIVE_COMPARATOR -
Interventions
NameTypeDescription
sotrastaurinDRUG -
placebo to sotrastaurinDRUG -
AveloxDRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:United States
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