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BMS-986337

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Feb 25, 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 Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04550195A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy ParticipantsPHASE1 COMPLETED 26Sep 17, 2020Mar 3, 2021Feb 25, 20221 Netherlands
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events (AEs)
Up to 30 days
Incidence of Serious Adverse Events (SAEs)
Up to 81 days
Incidence of AEs leading to discontinuation
Up to 30 days
Number of clinically significant changes in clinical laboratory values: Hematology tests
Up to 51 days
Number of clinically significant changes in clinical laboratory values: Urinalysis tests
Up to 51 days
Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Up to 51 days
Number of clinically significant changes from baseline in vital signs: Heart Rate
Up to 51 days
Number of clinically significant changes from baseline in vital signs: Body Temperature
Up to 51 days
Number of clinically significant changes from baseline in vital signs: Blood Pressure
Up to 51 days
Number of clinically significant changes from baseline in vital signs: Respiratory Rate
Up to 51 days
Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR)
Up to 51 days
Number of clinically significant changes from baseline in physical examinations
Up to 51 days
Number of clinically significant changes in ECG parameters: PR interval
Up to 51 days

PR interval is the time from the onset of the P wave to the start of the QRS complex

Number of clinically significant changes in ECG parameters: QRS duration
Up to 51 days

QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization

Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's)
Up to 51 days

QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave.

Number of clinically significant changes in ECG parameters: QT interval
Up to 51 days

The QT interval is the time from the start of the Q wave to the end of the T wave.

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A Single Ascending Dose (SAD) Cohort A1EXPERIMENTAL -
Part A SAD Cohort A2EXPERIMENTAL -
Part A SAD Cohort A3EXPERIMENTAL -
Part A SAD Cohort A4EXPERIMENTAL -
Part A SAD Cohort A5EXPERIMENTAL -
Part A SAD Cohort A6EXPERIMENTAL -
Part B Multiple Ascending Dose (MAD) Cohort B1EXPERIMENTAL -
Part B MAD Cohort B2EXPERIMENTAL -
Part B MAD Cohort B3EXPERIMENTAL -
Part B MAD Cohort B4EXPERIMENTAL -
Part C MAD in Japanese Healthy participants Cohort C1EXPERIMENTAL -
Part C MAD in Japanese Healthy participants Cohort C2EXPERIMENTAL -
Part C MAD in Japanese Healthy participants Cohort C3EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986337DRUGSpecified Dose on Specified Days
BMS-986337 PlaceboOTHERSpecified Dose on Specified Days
FamotidineBIOLOGICALSpecified Dose on Specified Days
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Eligibility Criteria
Age Range21 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations * For Japanese cohorts in Part C, must be first-generation Japanese (born in Japan, not living outside of Japan for more ...

Countries:Netherlands
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