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BMS-986120

Phase 1

Healthy Adult Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Sep 8, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986120 · 2 trials · 2 indications

Phase 1 2
NCT02439190CV004-007 Thrombosis Chamber StudyThrombosis
COMPLETED42 Analytics
NCT02208882Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986120 in Healthy Subjects and the Effects of Co-Administration of Midazolam and BMS-986120Healthy Adult Volunteers
COMPLETED24 Analytics
PHASE1COMPLETED
CV004-007 Thrombosis Chamber Study
Thrombosis
NCT0243919042
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PHASE1COMPLETED
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986120 in Healthy Subjects and the Effects of Co-Administration of Midazolam and BMS-986120
Healthy Adult Volunteers
NCT0220888224
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Study Endpoints

Primary Endpoints

Change from baseline in thrombus area (post-treatment with BMS-986120 vs. pre-treatment)
2 days
Safety and tolerability measured by number of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
Up to 168 days
Safety and tolerability measured by percent of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
Up to 168 days

Secondary Endpoints

Safety and tolerability of BMS 986120 or aspirin administered with and without clopidogrel based on adverse events,clinical laboratory tests, physical examinations and vital signs per the collection schedule
2 days
Maximum observed plasma concentration (Cmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam
Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Time of maximum observed plasma concentration (Tmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam
Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Treatment A: BMS-986120ACTIVE_COMPARATORBMS-986120 on specified days
Treatment B: Aspirin and ClopidogrelACTIVE_COMPARATORAspirin and Clopidogrel on specified days
Panel 1: BMS-986120 or PlaceboEXPERIMENTALBMS-986120 or Placebo multiple dose by mouth as specified
Panel 2: BMS-986120 or PlaceboEXPERIMENTALBMS-986120 or Placebo multiple dose by mouth as specified
Panel 3: BMS-986120 or Placebo + MidazolamEXPERIMENTALBMS-986120 or Placebo (multiple dose) + Midazolam (single dose) by mouth as specified
Panel 4: BMS-986120 or PlaceboEXPERIMENTALBMS-986120 or Placebo multiple dose by mouth as specified

Interventions

NameTypeDescription
BMS-986120DRUG -
AspirinDRUG -
ClopidogrelDRUG -
PlaceboDRUG -
MidazolamDRUG -
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Eligibility Criteria

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations * Body...

Countries:United KingdomUnited States
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Frequently asked questions about BMS-986120

What is BMS-986120 used for?

BMS-986120 is an investigational small molecule being studied in healthy adult volunteers and in patients with thrombosis. It is in Phase 1 clinical development and has not been approved by the FDA.

Who makes BMS-986120?

BMS-986120 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY.

What phase is BMS-986120 in?

BMS-986120 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in healthy volunteers and one in thrombosis. It remains an investigational drug and is not FDA approved.

What clinical trials is BMS-986120 in?

BMS-986120 has completed two Phase 1 trials. NCT02208882 evaluated multiple ascending doses in healthy subjects and the effects of co-administering midazolam. NCT02439190 was a thrombosis chamber study. Both trials were completed.

Is BMS-986120 the same as any other drug?

BMS-986120 is the only name provided for this investigational drug. No alternative names have been reported for it.