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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

CXL-1427 Ascending Dose · 1 trial · 1 indication

Phase 1 1
NCT02819271A First-in-Human Study of the Safety of Single Continuous Intravenous (IV) Infusions of CXL-1427 for up to 48 Hours in Healthy VolunteersHeart Failure
COMPLETED80 Analytics
PHASE1COMPLETED
A First-in-Human Study of the Safety of Single Continuous Intravenous (IV) Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers
Heart FailureUnlock trial analytics

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 to 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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Frequently asked questions about CXL-1427 Ascending Dose

What is CXL-1427 used for in Heart Failure?

CXL-1427 is an investigational small molecule being studied for the treatment of Heart Failure. It is administered as a single continuous intravenous (IV) infusion for up to 48 hours. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes CXL-1427?

CXL-1427 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety of this investigational drug for Heart Failure.

What phase is CXL-1427 in?

CXL-1427 is in Phase 1 clinical development. A first-in-human study of the drug has been completed, evaluating the safety of single continuous intravenous infusions for up to 48 hours in healthy volunteers. The drug remains investigational and is not yet approved.

What clinical trials is CXL-1427 in?

CXL-1427 has one completed Phase 1 clinical trial registered as NCT02819271. This first-in-human study assessed the safety of single continuous intravenous infusions of CXL-1427 for up to 48 hours in 80 healthy volunteers, with a placebo-controlled, randomized, double-blind design.

Is CXL-1427 FDA approved?

CXL-1427 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Heart Failure. The completed clinical trial focused on safety in healthy volunteers, and the drug has not yet progressed to later-stage studies or regulatory approval.