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BMS-986177

Phase 1

Thrombosis | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jun 10, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials9
Total Enrollment258
FDA Designations
No designations recorded
Clinical Trials (9)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03939702Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male ParticipantsPHASE1 COMPLETED 9 — — May 2, 2019Jul 11, 2019Oct 4, 20191 United States
NCT02982707Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy ParticipantsPHASE1 COMPLETED 26 — — Mar 1, 2018Sep 28, 2018Nov 14, 20183 United States
NCT03362437Evaluate the Pharmacokinetics of BMS-986177 From Two Formulations in Healthy ParticipantsPHASE1 COMPLETED 12 — — Nov 15, 2017Dec 28, 2017Mar 14, 20181 United Kingdom
NCT03196206Evaluate Pharmacokinetics and Safety of BMS-986177 in Participants With Normal Renal Function and With Moderate or Severe Renal ImpairmentPHASE1 COMPLETED 24 — — Jul 13, 2017Mar 4, 2018Jun 10, 20223 United States
NCT03224260To Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese ParticipantsPHASE1 COMPLETED 33 — — Jun 28, 2017Nov 7, 2017Jun 1, 20181 United States
NCT02902679A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis TreatmentPHASE1 COMPLETED 6 — — Nov 1, 2016Jun 1, 2017Jul 27, 20171 United States
NCT02959060A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy SubjectsPHASE1 COMPLETED 16 — — Nov 1, 2016Dec 1, 2016Jan 6, 2017 - —
NCT02807909A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Pharmacokinetics of BMS-986177 in Healthy SubjectsPHASE1 COMPLETED 28 — — Jul 1, 2016Aug 1, 2016Sep 12, 2016 - —
NCT02608970Safety and Tolerability Study of BMS-986177 in Healthy SubjectsPHASE1 COMPLETED 104 — — Dec 31, 2015Jul 23, 2017Jul 31, 20171 Belgium
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Study Endpoints
Primary Endpoints
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

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
Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177
Day 1-12
Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177
Day 1-12
Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177
Day 1-12
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH
Treatment Arms
ArmTypeDescription
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
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-986177DRUGAn orally administered anticoagulant to prevent and treat thromboembolic events
Matched PlaceboOTHEROral Suspension
RifampinDRUGSingle dose of BMS-986177 and multiple doses of Rifampin
ItraconazoleDRUG -
Diltiazem ERDRUG -
PlaceboOTHER -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Signed ICF * Healthy Male * Body mass index of 18.0 to 32.0 kg/m2, inclusive. * Agreement to use approved contraception for 94 days post treatment * Agreement to not donate sperm for 94 days post treatment Exclusion Criteria: * Acute or chronic illness * GI disease current o...

Countries:United StatesUnited KingdomBelgium
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Competitive Landscape -Thrombosis and Embolism 24 trials
CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN3PHASE3REGN7508, Apixaban, Enoxaparin, Acetylsalicylic Acid
Merit Medical Systems, Inc.MMSI5 — Undisclosed
AtriCure, Inc.ATRC1NAUndisclosed
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE2Thrombate infusion
Penumbra, Inc.PEN1NAUndisclosed
LeMaitre Vascular, Inc.LMAT2NAUndisclosed
Abbott LaboratoriesABT1 — Undisclosed
Pfizer Inc.PFE1 — Apixaban, Rivaroxaban, Edoxaban, Dabigatran, VKA
Novo Nordisk A/S Sponsored ADR Class BNVO1 — Undisclosed
Boston Scientific CorporationBSX1NAUndisclosed
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