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BMS-986141

Phase 2

Coronary Artery Disease | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Trials Updated: Dec 5, 2023

BMS-986141 development status

Highest phase Phase 2
Registered trials 5 across 1 sponsor since Jan 2015

BMS-986141 target and mechanism

Molecular targetF2RL3
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials5
Total Enrollment254

FDA Designations

No designations recorded

BMS-986141 clinical trials

BMS-986141 · 5 trials · 5 indications

Phase 2 2Phase 1 3
NCT05093790A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy ParticipantsCoronary Artery Disease
COMPLETED58 Analytics
NCT02671461Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"Thrombosis
COMPLETED16 Analytics
PHASE2COMPLETED
A Study to Evaluate BMS-986141 Added on to Aspirin or Ticagrelor or the Combination, on Thrombus Formation in a Thrombosis Chamber Model in Participants With Stable Coronary Artery Disease and Healthy Participants
Coronary Artery DiseaseUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"
ThrombosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Thrombus Area
Baseline, Day 1 hour 2, Day 2 hour 24

The change from baseline in thrombus area post-treatment with BMS-986141 versus pretreatment. Baseline is defined as the last non-missing result (including repeated and unscheduled assessments) with a collection date-time less than the datetime of study medication.

Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28
28 Days

The incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 was to be reported by arm in all treated participants.

Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period
Up to 90 days

The percentage of participants with composite of major bleeding and CRNM bleeding was to be reported. Point estimates and 95% CIs for event rates were to be presented by treatment, together with point estimates and 95% CIs for the difference of event rates between each BMS-986141 arm and placebo.

Maximum observed plasma concentration (Cmax) of BMS-986141
Days 1-22
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141
Days 1-22
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141
Days 1-22
Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141
Days 1-22
Maximum observed concentration (Cmax)
Days 1-21
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Days 1-21
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T))
Days 1-21
Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Up to 30 days post discontinuation of dosing or last participation in the study

Serious adverse event (SAE) Adverse event (AE) Electrocardiogram (ECG)

Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Up to 30 days post discontinuation of dosing or last participation in the study
Safety measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Up to 30 days post discontinuation of dosing or last participation in the study
Tolerability measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Up to 30 days post discontinuation of dosing or last participation in the study

Secondary Endpoints

Number of Participants Experiencing Abnormal Vital Signs
Vital signs will be collected at check-in and prior to and after each chamber assessment on Days 1 and 2
Number of Participants Experiencing Abnormal Electrocardiogram (ECG) Values
Electrocardiograms were collected at check-in, and 2 and 24 hours after dosing
Number of Participants Experiencing Clinical Lab Abnormalities
From baseline up to 24 hours post dose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Arm 1: Ticagrelor + BMS-986141EXPERIMENTAL -
Treatment Arm 2: Aspirin + BMS-986141EXPERIMENTAL -
Treatment Arm 3: Ticagrelor + Aspirin + BMS-986141EXPERIMENTAL -
Treatment Arm 4: BMS-986141EXPERIMENTAL -
BMS-986141 0.8mgEXPERIMENTALBMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets)
BMS-986141 4.8mgEXPERIMENTALBMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets)
PlaceboPLACEBO_COMPARATORPlacebo orally (tablets) and ASA 75 to 162 mg orally (tablets)
BMS 986141 and RifampinEXPERIMENTAL -
BMS-986141 and DilitazemEXPERIMENTAL -
Part A Panel 1: BMS-986141 or PlaceboEXPERIMENTALBMS-986141 or Placebo single dose by mouth as specified
Part A Panel 2: BMS-986141 or PlaceboEXPERIMENTALBMS-986141 or Placebo single dose by mouth as specified
Part A Panel 3: BMS-986141 or PlaceboEXPERIMENTALBMS-986141 or Placebo single dose by mouth as specified
Part A Panel 4: BMS-986141 or PlaceboEXPERIMENTALBMS-986141 or Placebo single dose by mouth as specified
Part A Panel 5: BMS-986141 or PlaceboEXPERIMENTALBMS-986141 or Placebo single dose by mouth as specified
Part A Panel 6: BMS-986141 or PlaceboEXPERIMENTALBMS-986141 or Placebo single dose by mouth as specified
Part A Panel 7: BMS-986141EXPERIMENTALSingle dose by mouth as specified
Part A Panel 8: BMS-986141EXPERIMENTALSingle dose by mouth as specified
Part B Panel 1: BMS-986141 or PlaceboEXPERIMENTALBMS-986141 or Placebo by mouth as specified
Part B Panel 2: BMS-986141 or PlaceboEXPERIMENTALBMS-986141 or Placebo by mouth as specified
Part B Panel 3: BMS-986141 or PlaceboEXPERIMENTALBMS-986141 or Placebo by mouth as specified
Part C Panel 1: BMS-986141 or PlaceboEXPERIMENTALBMS-986141 or Placebo by mouth as specified
Part C Panel 2: BMS-986141 or PlaceboEXPERIMENTALBMS-986141 or Placebo by mouth as specified
Part C Panel 3: BMS-986141 or PlaceboEXPERIMENTALBMS-986141 or Placebo by mouth as specified
Part D Panel 1: BMS-986141 and AspirinEXPERIMENTALBMS-986141 and Aspirin by mouth as specified
Part D Panel 1: Placebo matching BMS-986141 and AspirinPLACEBO_COMPARATORBMS-986141 placebo and Aspirin by mouth as specified
Part E Panel 1: BMS-986141 and ItraconazoleEXPERIMENTALBMS-986141 and Itraconazole by mouth as specified

Interventions

NameTypeDescription
TicagrelorDRUGSpecified dose on specified days
BMS-986141DRUGSpecified dose on specified days
AspirinDRUGSpecified dose on specified days
PlaceboOTHER -
BMS 986141DRUGTwo single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)
RifampinDRUGTwo single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)
DilitazemDRUGSingle dose BMS-986141 and Multiple doses of Dilitazem
ItraconazoleDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: * Male or female between 18 to 75 years of age, inclusive, and body mass index (weight kg/m2) between 18 and 35 kg/m2 (inclusive), and body weight 50 kg and 1...

Countries:United KingdomUnited StatesJapan
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Frequently asked questions about BMS-986141

What is BMS-986141?

BMS-986141 is an investigational small molecule developed by Bristol-Myers Squibb Company (NYSE: BMY) for atherothrombotic diseases, including coronary artery disease, ischemic stroke, and thrombosis. It is a protease activated receptor-4 antagonist being studied to reduce the chances of additional strokes or mini strokes.

What does BMS-986141 target?

BMS-986141 targets F2RL3, also known as protease activated receptor-4 (PAR-4). It acts as an antagonist at this receptor. The compound is a small molecule designed to inhibit PAR-4 mediated platelet activation, which is being explored in the setting of thrombosis and atherothrombotic disease.

Who makes BMS-986141?

BMS-986141 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the clinical studies evaluating the compound in thrombosis-related conditions.

What phase is BMS-986141 in?

BMS-986141 is in Phase 1 development and is investigational. It has not been approved by the FDA. Completed studies include Phase 1 pharmacokinetic trials and Phase 2 studies in coronary artery disease and thrombosis, with no active trials currently listed.

What clinical trials is BMS-986141 in?

BMS-986141 has been studied in completed trials including NCT05093790, which evaluated it added on to aspirin or ticagrelor in stable coronary artery disease; NCT02957448, a rifampin drug interaction study; NCT02922452, a diltiazem pharmacokinetic study; and NCT02671461, a Phase 2 study in thrombosis.

Is BMS-986141 the same as BMS 986141?

Yes, BMS-986141 and BMS 986141 refer to the same investigational compound. The difference is only in punctuation, with the hyphenated form used in the drug name and the spaced form appearing as an alternative name in study records and literature.