Recent Updates
Recently added Catalysts

BMS-914832

Phase 1

Atrial Fibrillation | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Feb 2, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01211808Effect of Diltiazem on Pharmacokinetics of BMS-914392PHASE1 COMPLETED 24Sep 1, 2010Oct 1, 2010Feb 2, 20111 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Pharmacokinetics of single dose of BMS-914393 derived from serial measurements of BMS-914392 plasma concentrations
Pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 8, 12, 24, 48, 72, and 96 hours after dosing of BMS-914392 alone or in combination with diltiazem
Secondary Endpoints
The effect of multiple doses of BMS-914392 on PR, QRS, RR, and QTc intervals derived from serial electrocardiograms (ECGs)
Pre-dose and 0.5 Hr, 1 Hr, 1.5 Hr, 2 Hr, 3 Hr, 4 Hr , 6 Hr, 8 Hr, 12 Hr, 24 Hr after dosing of BMS-914392 alone or in combination with diltiazem
Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392
Daily
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Treatment A (BMS-914832)EXPERIMENTAL -
Treatment B (BMS-914832 + diltiazem)EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-914832DRUGTablets, Oral, 30 mg, once, 1 day
DiltiazemDRUGTablets, Oral, 360 mg, once daily, 10 days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avo...

Countries:United States
Unlock Eligibility Criteria