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BMS-914392

Phase 2

Atrial Fibrillation | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Oct 12, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

BMS-914392 · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT01356914Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation BurdenAtrial Fibrillation
COMPLETED20 Analytics
PHASE2COMPLETED
Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden
Atrial FibrillationUnlock trial analytics

Study Endpoints

Primary Endpoints

Atrial Fibrillation Burden
At screening (baseline)
Pharmacokinetics of single dose of metoprolol derived from serial measurements of metoprolol plasma concentrations
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, and 36 Hr after dosing of metoprolol alone or in combination with BMS-914392

Secondary Endpoints

Number of participants with adverse events and type of adverse events
At Day 1 of each cross-over period
Number of Atrial fibrillation (AF) episodes
At Day 1 of each cross-over period
Number of AF episodes
At Day 8 of each cross-over period
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment A: BMS-914392EXPERIMENTAL -
Treatment B: BMS-914392EXPERIMENTAL -
Treatment C: BMS-914392EXPERIMENTAL -
Treatment D: PlaceboPLACEBO_COMPARATOR -
metoprololOTHERTreatment A
BMS-914392 + metoprololEXPERIMENTALTreatment B

Interventions

NameTypeDescription
BMS-914392DRUGTablets, Oral, 10 mg, Every Day (QD), 20 days
PlaceboDRUGTablets, Oral, 0 mg, Three Times Daily (TID), 20 days
metoprololDRUGTablets, Oral, 200 mg, once, 1 day
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Paroxysmal atrial fibrillation (AF) * Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics. * 1-50% AF burden on pacemaker interrogation at screening. * Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception t...

Countries:United KingdomUnited States
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Frequently asked questions about BMS-914392

What is BMS-914392 used for?

BMS-914392 is an investigational small molecule being developed by Bristol-Myers Squibb for the treatment of atrial fibrillation, a condition characterized by an irregular and often rapid heart rate. It has been studied in clinical trials to evaluate its effects on atrial fibrillation burden and its potential interaction with other medications.

Who is developing BMS-914392?

BMS-914392 is being developed by Bristol-Myers Squibb Company, a global biopharmaceutical company. The company's stock is traded under the ticker symbol BMY on the New York Stock Exchange. Bristol-Myers Squibb has conducted clinical trials to assess the safety and efficacy of BMS-914392 in patients with atrial fibrillation.

What phase is BMS-914392 in?

BMS-914392 is in Phase 2 clinical development. It has completed two clinical trials, including a Phase 1 study and a Phase 2 study, both of which have been completed. The drug is still investigational and has not been approved by regulatory authorities for the treatment of atrial fibrillation.

What clinical trials has BMS-914392 been in?

BMS-914392 has been studied in two completed clinical trials. The first, NCT01211821, was a Phase 1 study in the United States that evaluated the effect of BMS-914392 on the pharmacokinetics of metoprolol in healthy volunteers. The second, NCT01356914, was a Phase 2 study in the United Kingdom that assessed the effect of BMS-914392 on atrial fibrillation burden using pacemaker Holter monitoring.

Is BMS-914392 FDA approved?

BMS-914392 is not FDA approved. It is an investigational drug that has been evaluated in clinical trials for atrial fibrillation, but it has not received approval from the U.S. Food and Drug Administration or any other regulatory agency. The drug remains in clinical development and its safety and efficacy have not been fully established.