Recent Updates
Recently added Catalysts

BMS-986177

Phase 2

Acute Ischemic Stroke | Small molecule | Neurology |Bristol-Myers Squibb Company|Last Updated: Aug 21, 2023

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment2,366

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986177 · 13 trials · 7 indications

Phase 2 1Phase 1 12
NCT03766581A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and ClopidogrelAcute Ischemic Stroke
COMPLETED2,366 Analytics
PHASE2COMPLETED
A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
Acute Ischemic Stroke
NCT037665812,366
Unlock trial analytics

Study Endpoints

Primary Endpoints

Percent of Participants With Model Based Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90
From randomization to up to 90 days after randomization

Model based assessment estimate for composite event is a customized statistical analysis called MCP-MOD (Multiple Comparison Procedures, MODel) estimation, which is used to check for dose-response relationship. 95% confidence interval (CI) for composite event based on bootstrap (10000 samples).

Absolute Bioavailability (F)
Day 1 of Treatment Periods 1-5 (up to approximately 7 weeks)

Absolute bioavailability is defined as the amount of drug from a formulation that reaches the systemic circulation relative to an intravenous (IV) dose. Treatment A (milvexian oral solution with IV microdose) was assessed versus each treatment phase of milvexian administered as: a oral solution (fasted), high dose SDD (Spray-Dried Dispersion) capsule (fed and fasted) and low dose SDD capsule (fed and fasted).

Assess PK Cmax of a dose of [14C]BMS-986177
Day 1-12

Cmax

Assess PK AUC(INF) of a dose of [14C]BMS-986177
Day 1-12

AUC(INF)

Assess PK AUC(0-T) of a dose of [14C]BMS-986177
Day 1-12

AUC(0-T)

Assess PK Tmax of a dose of [14C]BMS-986177
Day 1-12

Tmax

Assess PK T-HALF of a dose of [14C]BMS-986177
Day 1-12

T-HALF

Assess PK CL/F of a dose of [14C]BMS-986177
Day 1-12
Assess PK Vz/F of a dose of [14C]BMS-986177
Day 1-12

Vz/F

Assess PK AUC of a dose of [14C]BMS-986177
Day 1-12

AUC(BMS-986177)

Assess PK AUC(TRA) of a dose of [14C]BMS-986177
Day 1-12

AUC(TRA)

Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177
Day 1-12

Plasma AUC(TRA)

Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177
Day 1-12

Blood AUC(TRA)

Assess the CLR of [14C]BMS-986177
Day 1-12

CLR

Assess the %UR of [14C]BMS-986177
Day 1-12

%UR

Assess the %FE of [14C]BMS-986177
Day 1-12

%FE

Assess the %BE of [14C]BMS-986177
Day 1-12

%BE (if applicable)

Assess the %Total recovery of [14C]BMS-986177
Day 1-12

%Total recovery

Incidence of Adverse Events (AEs)
Up to Day 33
Incidence of Serious Adverse Events (SAEs)
Up to Day 95
Incidence of Adverse Events (AEs) leading to discontinuation
Up to Day 33
Number of participants with vital sign abnormalities
Up to Day 33
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Up to Day 33
Number of participants with clinical laboratory abnormalities
Up to Day 33
Number of participants with physical examination abnormalities
Up to Day 33
Maximum observed plasma concentration (Cmax) of BMS-986177
Up to 5 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-987177
Up to 5 days
Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177
Up to 5 days
Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177
Up to 5 days
Maximum observed plasma concentration (Cmax)
Up to 3 days

Measured by plasma concentration

AUC from time zero to time of last quantifiable concentration (AUC(0-T))
Up to 3 days

Measured by plasma concentration

AUC from time zero extrapolated to infinite time (AUC(INF))
Up to 3 days

Measured by plasma concentration

Number of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation when coadministered BMS-986177 (twice daily) and aspirin (once daily)
Up to 10 days

Safety and tolerability of multiple doses of BMS-986177 measured by investigator assessment

Number of potential clinically significant changes in electrical activity of the heart in participants coadministered BMS-986177 (twice daily) and aspirin (once daily)
Up to 10 days

Measured by electrocardiogram (ECG)

Number of participants with vital sign abnormalities.
Up to 10 days
Number of participants with physical examination abnormalities.
Up to 10 days
Number of participants with clinical laboratory abnormalities.
Up to 10 days
AUC from time zero to time of last quantifiable concentration (AUC (0-T))
Up to 5 days

Summary measures of PK parameters

AUC from time zero extrapolated to infinite time (AUC (INF))
Up to 5 days

Summary measures of PK parameters

Occurrence of Death
30 days after last dose

Measured by investigator assessment

Incidence of Adverse Events (AEs) Leading to Discontinuation of Study Therapy
17 days

Measured by investigator assessment

Incidence of Adverse Events (AEs) Resulting in Clinically Significant Bleeding
17 days

Measured by investigator assessment

Changes in Vital Signs (heart rate, systolic blood pressure, diastolic blood pressure, respiration rate, and temperature)
17 days

Measured by investigator assessment

Change from baseline in electrocardiogram findings (ECGs)
17 days

Measured by investigator assessment

To assess the Number of subjects with Adverse events (AEs).
Day -1 - day 3
To assess the Change from baseline in Physical examination parameters.
Day -1 - day 3
To assess the change from baseline in Electrocardiogram (ECG) assessment.
Day -1 - day 3
To assess the change from baseline in clinical laboratory values.
Day -1 - day 3
To assess the change from baseline in vital signs assessment.
Day -1 - day 3
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Days1-15
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Days1-15
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) of BMS-986177
Days 1-12
Maximum observed concentration (Cmax)
Days 1-12
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Days 1-12
Safety of single dose of BMS-986177 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
Approximately 3 days

Adverse event (AE), Serious adverse event (SAE)

Safety of multiple dose of BMS-986177 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
Approximately 16 days
Tolerability of single dose of BMS-986177 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
Approximately 3 days
Tolerability of multiple dose of BMS-986177 measured by number of subjects who experience SAE, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
Approximately 16 days

Secondary Endpoints

Percent of Participants With Major Bleeding According to BARC Type 3 and 5
From first dose to up to 107 days after first dose
Number of Participants With Bleeding Based on BARC Types 1-5
From first dose to up to 107 days after first dose
Number of Participants With Bleeding Based on ISTH-Defined Criteria
From first dose to up to 107 days after first dose
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
BMS-986177 PlaceboPLACEBO_COMPARATORSpecified Dose on Specified Days
Dose 1: BMS-986177 + Aspirin + ClopidogrelEXPERIMENTALSpecified Dose on Specified Days
Dose 2: BMS-986177 + Aspirin + ClopidogrelEXPERIMENTALSpecified Dose on Specified Days
Dose 3: BMS-986177 + Aspirin + ClopidogrelEXPERIMENTALSpecified Dose on Specified Days
Dose 4: BMS-986177 + Aspirin + ClopidogrelEXPERIMENTALSpecified Dose on Specified Days
Dose 5: BMS-986177 + Aspirin + ClopidogrelEXPERIMENTALSpecified Dose on Specified Days
Dose 6: BMS-986177 + Aspirin + ClopidogrelEXPERIMENTALSpecified Dose on Specified Days
Dose 7: BMS-986177 + Aspirin + ClopidogrelEXPERIMENTALSpecified Dose on Specified Days
Treatment Sequence 1EXPERIMENTAL -
Treatment Sequence 2EXPERIMENTAL -
Treatment Sequence 3EXPERIMENTAL -
Treatment Sequence 4EXPERIMENTAL -
Non-Bile CollectionACTIVE_COMPARATOROn Day 1, all participants will receive a single oral solution dose of 200 mg \[14C\] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12
Bile CollectionACTIVE_COMPARATOROn Day 1, all participants will receive a single oral solution dose of 200 mg \[14C\] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Approximately 1 hour after study drug administration, an ND tube may be positioned in approximately 3 selected participants for collection of bile.Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12
BMS-986177 + Aspirin + Clopidogrel (Part 1)EXPERIMENTALBMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
BMS-986177 (Part 1)EXPERIMENTALBMS-986177 200 mg capsule twice daily (days 1-5)
BMS-986177 placebo + Aspirin + Clopidogrel (Part 1)PLACEBO_COMPARATORBMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg once daily (day 1) then 75 mg tablet once daily (days 2-5)
BMS-986177 (Part 2)EXPERIMENTALBMS-986177 200 mg capsule twice daily (days 1-5)
BMS-986177 placebo + Clopidogrel (Part 2)PLACEBO_COMPARATORBMS-986177 placebo match capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
BMS-986177 + Clopidogrel (Part 2)EXPERIMENTALBMS-986177 200 mg capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
BMS-986177 (Part 3)EXPERIMENTALBMS-986177 200 mg capsule twice daily (days 1-5)
BMS-986177 placebo + Aspirin (Part 3)PLACEBO_COMPARATORBMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)
BMS-986177 + Aspirin (Part 3)EXPERIMENTALBMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)
Mild Hepatic SubjectsEXPERIMENTALSubjects are given a single dose of BMS-986177
Moderate Hepatic SubjectsEXPERIMENTALSubjects are given a single dose of BMS-986177
Healthy Match SubjectsEXPERIMENTALSubjects are given a single dose of BMS-986177
Treatment AEXPERIMENTALReceive 200 mg BMS-986177 Form A without food
Treatment BEXPERIMENTALReceive 200 mg BMS-986177 Form B without food
Treatment CEXPERIMENTALReceive 200 mg BMS-986177 Form B with food
AspirinACTIVE_COMPARATOR325 mg tablet, once daily for 5 days (Day -5 to -1)
BMS-986177 plus aspirinEXPERIMENTAL200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Placebo plus aspirinPLACEBO_COMPARATOR200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7)
Group AEXPERIMENTALNormal Renal Function
Group BEXPERIMENTALModerate Renal Impairment
Group CEXPERIMENTALSevere Renal Impairment
End Stage Renal Disease SubjectsEXPERIMENTALSubjects given a single oral dose of BMS-986177 before (Period 1) and after (Period 2) a hemodialysis session
BMS-986177 and RifampinEXPERIMENTAL -
BMS-986177 and ItraconazoleEXPERIMENTALSingle dose BMS-986177 on day 1 followed by Itraconazole and BMS-986177 on specified days
BMS-986177 and DiltiazemEXPERIMENTALSingle dose BMS-986177 on day 1 followed by Diltiazem ER and BMS-986177 on specified days
BMS-986177EXPERIMENTALBMS-986177 specified dose on specified days
PlaceboOTHERPlacebo specified dose on specified days

Interventions

NameTypeDescription
BMS-986177DRUGOral administration
PlaceboOTHEROral Administration
ClopidogrelDRUGOral administration
AspirinDRUGOral administration
BMS-986177 Oral SolutionDRUGSpecified dose on specified days
[14C]BMS-986177 Solution for InfusionDRUGSpecified dose on specified days
BMS-986177 Spray-dried Dispersion CapsulesDRUGSpecified dose on specified days
Placebo (for BMS-986177)OTHERBMS-986177 placebo match capsule
Matched PlaceboOTHEROral Suspension
RifampinDRUGSingle dose of BMS-986177 and multiple doses of Rifampin
ItraconazoleDRUG -
Diltiazem ERDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites424

Inclusion Criteria: * Male and Female ≥40 years of age * Acute Ischemic Stroke or Transient Ischemic Attack * Intracranial or Extracranial Atherosclerotic Plaque proximal to the affected brain area Exclusion Criteria: * Predicted inability to swallow study medication * Any condition that, in the ...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChileChinaCzechiaDenmarkFinlandFranceGermanyGreeceHong KongHungaryIsraelItalyJapanMexicoNorwayPolandRussiaSouth KoreaSpainSwedenSwitzerlandUnited Kingdom
Unlock Eligibility Criteria

Frequently asked questions about BMS-986177

What is BMS-986177 used for?

BMS-986177 is an investigational small molecule being studied for acute ischemic stroke, thrombosis, and in healthy volunteers. It is in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated for its safety and efficacy in these conditions.

Who makes BMS-986177?

BMS-986177 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in various patient populations.

What phase is BMS-986177 in?

BMS-986177 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received FDA approval. The drug is being studied for acute ischemic stroke, thrombosis, and in healthy volunteers to assess its safety and pharmacological properties.

What clinical trials is BMS-986177 in?

BMS-986177 has completed nine clinical trials with a total enrollment of 2,366 participants. Notable trials include NCT03196206, which evaluated pharmacokinetics and safety in participants with normal renal function and moderate or severe renal impairment, and NCT03341390, which assessed the effect of BMS-986177 on aspirin in healthy participants.

Is BMS-986177 the same as milvexian?

Yes, BMS-986177 is also known as milvexian. A completed Phase 1 trial, NCT04965389, studied milvexian using an IV microtracer with additional formulation and food effect comparison in healthy participants, confirming the alternative name.