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CXL-1427 Ascending Dose

Phase 1

Heart Failure | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Jan 23, 2017

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 Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02819271A First-in-Human Study of the Safety of Single Continuous Intravenous (IV) Infusions of CXL-1427 for up to 48 Hours in Healthy VolunteersPHASE1 COMPLETED 80Feb 1, 2014Apr 1, 2014Jan 23, 2017 -
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Study Endpoints
Primary Endpoints
Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs)
Up to 31 days
Tolerability measured by percentage of Treatment Emergent Adverse Events (TEAEs)
Up to 31 days
Secondary Endpoints
Steady-state plasma concentration (Css)
Up to 4 days
Area under the plasma concentration (AUC) vs. time curve
Up to 4 days
Terminal elimination half-life (1/2)
Up to 4 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CXL-1427 (BMS-986231)EXPERIMENTALExperimental
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
CXL-1427 Ascending DoseDRUG -
PlaceboOTHER -
CXL-1427 Descending DoseDRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No evidence of any acute or chronic health disorder * Not have taken any prescription medication within 15 days of study entry * Not have taken any over-the-counter medication or herbal/vitamin supplement within 3 days of study entry * Not have not have any dietary restriction...

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