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BMS-394136

Phase 1

Heart Diseases | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Aug 20, 2008

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00162448A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or DefibrillatorsPHASE1 COMPLETED 36Jan 1, 2005 -Aug 20, 20083 United States
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Study Endpoints
Primary Endpoints
Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)
Secondary Endpoints
Effect of BMS-394136 on atrial vs ventricular refractoriness
Effect of BMS-394136 on the QTc interval
Assess the safety and tolerability of a single dose of BMS-394136
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
A1EXPERIMENTAL -
A2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BMS-394136DRUGOral Solution, Oral, 100 mg, Single dose, 1 day.
PlaceboDRUGOral Solution, Oral, 0 mg, Single dose, 1 day.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patients with dual-chamber pacemakers or defibrillators Exclusion Criteria: * Recent acute ischemic events * Recent atrial or ventricular arrhythmias * Uncompensated heart failure * Amiodarone use within last year * Women of childbearing potential * QTc \<430 msec males * QT...

Countries:United States
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