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BMS-986177

Phase 2

Acute Ischemic Stroke | Small molecule | Neurology |Bristol-Myers Squibb Company|Trials Updated: Jun 12, 2023

BMS-986177 development status

Highest phase Phase 2
Registered trials 13 across 1 sponsor since Nov 2015

BMS-986177 target and mechanism

ModalitySmall molecule

Also known as BMS-986177 Oral Solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials11
Total Enrollment2,656

FDA Designations

No designations recorded

BMS-986177 clinical trials

BMS-986177 · 11 trials · 7 indications

Phase 2 1Phase 1 10
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
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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).

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

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

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 Serious Adverse Events (SAEs)
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

The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death
From the date of patient's written consent to participate in study until 30 days after discontinuation of dosing or patient's participation in study (up to October 2017)

Safety and tolerability of single oral doses of BMS-986177 in patients with end-stage renal disease (ESRD) on chronic hemodialysis (HD) treatment as measured by the number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation and death

The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.

HEMATOLOGY I; HEMOGLOBIN HB G/DL LOW \< 0.85\*PRE-RX; HEMATOCRIT HCT % LOW \< 0.85\*PRE-RX; PLATELET COUNT PLAT X10\*9 C/L LOW \< 0.85\*LLN IF PRE-RX IS MISSING; \< 0.85\*LLN IF PRE-RX \>= LLN; \< 0.85\*PRE-RX IF PRE-RX \< LLN; HIGH \> 1.5\*ULN; HEMATOLOGY II; LEUKOCYTES WBC X10\*3 C/UL LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF LLN \<= PRE-RX \<= ULN; \< 0.85\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.2\*ULN IF PRE-RX IS MISSING; \> 1.2\*ULN IF LLN \<= PRE-RX \<= ULN; \> 1.5\*PRE-RX IF PRE-RX \> ULN; NEUTROPHILS (ABSOLUTE) NEUTA X10\*3 C/UL LOW \< 1.5 IF PRE-RX IS MISSING; \< 1.5 IF PRE-RX \>= 1.5; \< 0.85\*PRE-RX IF; PRE-RX \< 1.5; LYMPHOCYTES (ABSOLUTE) LYMPA X10\*3 C/UL LOW \< 0.75; HIGH \> 7.5; MONOCYTES (ABSOLUTE) MONOA X10\*3 C/UL HIGH \> 2; BASOPHILS (ABSOLUTE) BASOA X10\*3 C/UL HIGH \> 0.4; EOSINOPHILS (ABSOLUTE) EOSA X10\*3 C/UL HIGH \> 0.75; COAGULATION: PROTHROMBIN TIME (PT) PT SEC HIGH \> 1.5\*ULN; APTT APTT SEC HIGH \> 1.5\*ULN; INTL NORMALIZED RATIO (INR) INR FRACTION HIGH \> 1.5\*ULN;

The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.

LIVER \& KIDNEY FUNCTION; ALKALINE PHOSPHATASE (ALP) ALP U/L HIGH \> 1.25\*ULN IF PRE-RX IS MISSING; \> 1.25\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L HIGH \> 1.25\*ULN IF PRE-RX IS MISSING; \> 1.25\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L HIGH \> 1.25\*ULN IF PRE-RX IS MISSING; \> 1.25\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; BILIRUBIN, TOTAL TBILI MG/DL HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; BILIRUBIN, DIRECT DBILI MG/DL HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; BLOOD UREA NITROGEN BUN MG/DL HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.2\*PRE-RX IF PRE-RX \> ULN; CREATININE CREAT MG/DL HIGH \> 1.5\*ULN IF PRE-RX IS MISSING; \> 1.5\*ULN IF PRE-RX \<= ULN; \> 1.33\*PRE-RX IF PRE-RX \> ULN;

The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge

ELECTROLYTES: SODIUM, SERUM NA MEQ/L LOW \< 0.95\*LLN IF PRE-RX IS MISSING; \< 0.95\*LLN IF PRE-RX \>= LLN; \< 0.95\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.05\*ULN IF PRE-RX IS MISSING; \> 1.05\*ULN IF PRE-RX \<= ULN; \> 1.05\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; POTASSIUM, SERUM K MEQ/L LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF PRE-RX \>= LLN; \< 0.9\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.1\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; CHLORIDE, SERUM CL MEQ/L LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF PRE-RX \>= LLN; \< 0.9\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.1\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN;

The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)
At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.

ELECTROLYTES (CONT.): CALCIUM, TOTAL CA MG/DL LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF PRE-RX \>= LLN; \< 0.9\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.1\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; PHOSPHORUS, INORGANIC PHOS MG/DL LOW \< 0.85\*LLN IF PRE-RX IS MISSING; \< 0.85\*LLN IF PRE-RX \>= LLN; \< 0.85\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.25\*ULN IF PRE-RX IS MISSING; \> 1.25\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; MAGNESIUM, SERUM MG MEQ/L LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF PRE-RX \>= LLN; \< 0.9\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.1\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN

The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.

GLUCOSE, FASTING SERUM GLUCF MG/DL LOW \< 0.8\*LLN IF PRE-RX IS MISSING; \< 0.8\*LLN IF PRE-RX \>= LLN; \< 0.8\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.3\*ULN IF PRE-RX IS MISSING \> 1.3\*ULN IF PRE-RX \<= ULN; \> 2\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; PROTEIN, TOTAL TPRO G/DL LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF PRE-RX \>= LLN; \< 0.9\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.1\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; ALBUMIN ALB G/DL LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF PRE-RX \>= LLN; \< 0.9\*PRE-RX IF PRE-RX \< LLN; CREATINE KINASE (CK) CK U/L HIGH \> 1.5\*ULN IF PRE-RX IS MISSING; \> 1.5\*ULN IF PRE-RX \<= ULN; \> 1.5\*PRE-RX IF PRE-RX \> ULN; URIC ACID URIC MG/DL HIGH \> 1.2\*ULN IF PRE-RX IS MISSING; \> 1.2\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; LACTATE DEHYDR (LD) LD U/L HIGH \> 1.25\*ULN IF PRE-RX IS MISSING; \> 1.25\*ULN IF PRE-RX \<= ULN; \> 1.5\*PRE-RX IF PRE-RX \> ULN

The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies
At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.

URINALYSIS I; BLOOD, URINE UBLD N/A HIGH \>= 2 IF PRE-RX IS MISSING; \>= 2 IF PRE-RX \< 1; \>= 2 IF PRE-RX \>= 1 SPECIAL STUDIES; OCCULT BLOOD SCREEN, FECES OCBLD N/A HIGH NEGATIVE PRE-RX CHANGING TO POSITIVE

The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate
Days -3 to -1, Days 1, 5, 8, and 12.

Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate
Days -3 to -1, Days 1, 5, 8, and 12.

Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate
Days -3 to -1, Days 1, 5, 8, and 12.

Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate
Days -3 to -1, Days 1, 5, 8, and 12.

Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate
Days -3 to -1, Days 1, 5, 8, and 12

QTcF = QT corrected for heart rate using the Fridericia formula Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.

The Change From Baseline in Vital Signs: Diastolic Blood Pressure
Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15
The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)
Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15
The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)
Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15
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
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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
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
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
Group AEXPERIMENTALNormal Renal Function
Group BEXPERIMENTALModerate Renal Impairment
Group CEXPERIMENTALSevere Renal Impairment
Dose Sequence 1ACTIVE_COMPARATORUFH, BMS-986177 - dose 1, BMS-986177 - dose 2, Enoxaparin
Dose Sequence 2ACTIVE_COMPARATORBMS-986177 - dose 1, Enoxaparin, UFH, BMS-986177 - dose 2
Dose Sequence 3ACTIVE_COMPARATORBMS-986177 - dose 2, UFH, Enoxaparin, BMS-986177 - dose 1
Dose Sequence 4ACTIVE_COMPARATOREnoxaparin, BMS-986177 - dose 2, BMS-986177 - dose 1, UFH
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
Matched PlaceboOTHEROral Suspension
EnoxaparinDRUGSpecified dose of Enoxaparin on specified days
unfractionated heparin (UFH)DRUGSpecified dose of UFH on specified days
RifampinDRUGSingle dose of BMS-986177 and multiple doses of Rifampin
ItraconazoleDRUG -
Diltiazem ERDRUG -
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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
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Frequently asked questions about BMS-986177

What is BMS-986177 used for?

BMS-986177 is an investigational oral antithrombotic being studied for the prevention of stroke in patients with acute ischemic stroke or transient ischemic attack, and more broadly for thrombosis. It has been evaluated in a Phase 2 trial in patients receiving aspirin and clopidogrel, and in Phase 1 studies in healthy participants.

Who is developing BMS-986177?

BMS-986177 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company has sponsored the clinical program, including the Phase 2 stroke prevention study and several Phase 1 pharmacokinetic trials.

What phase is BMS-986177 in?

BMS-986177 is in Phase 2 development. Nine clinical trials have been completed, including one Phase 2 study and multiple Phase 1 studies, with no active trials currently listed. The Phase 2 trial enrolled 2,366 patients and evaluated the drug for stroke prevention.

What clinical trials is BMS-986177 in?

BMS-986177 has been studied in completed trials including NCT03766581, a Phase 2 trial of stroke prevention in patients receiving aspirin and clopidogrel, and Phase 1 trials NCT03939702, NCT03362437, and NCT03224260. The Phase 1 studies evaluated pharmacokinetics, metabolism, and safety in healthy participants.

Is BMS-986177 the same as BMS-986177 Oral Solution?

Yes, BMS-986177 Oral Solution is an alternative name for BMS-986177. Both refer to the same investigational small molecule developed by Bristol-Myers Squibb for antithrombotic use, including acute ischemic stroke and thrombosis.

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