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BMS-986337

Phase 1

Undisclosed | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Feb 25, 2022

BMS-986337 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

BMS-986337 clinical trials

BMS-986337 · 1 trial · 1 indication

Phase 1 1
NCT04550195A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy ParticipantsHealthy Volunteers
COMPLETED26 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants
Healthy VolunteersUnlock trial analytics

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 to 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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Frequently asked questions about BMS-986337

What is BMS-986337?

BMS-986337 is an investigational small molecule being developed by Bristol-Myers Squibb Company (NYSE: BMY). It has been studied in a Phase 1 clinical trial in healthy volunteers. The specific disease or condition it is intended to treat has not been disclosed, and it remains in early clinical development.

Who makes BMS-986337?

BMS-986337 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. Bristol-Myers Squibb sponsored the Phase 1 study of the compound conducted in the Netherlands.

What phase is BMS-986337 in?

BMS-986337 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound has not been approved by the FDA and remains investigational.

What clinical trials is BMS-986337 in?

BMS-986337 has been evaluated in one clinical trial, NCT04550195, titled "A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants." The Phase 1 study enrolled 26 healthy volunteers in the Netherlands, was randomized, double-blind, and controlled, and is now completed.

Is BMS-986337 FDA approved?

No. BMS-986337 is an investigational drug in Phase 1 clinical development and has not been approved by the FDA. Its only completed trial studied safety, tolerability, and drug levels in healthy participants rather than in patients with a specific disease.

What is BMS-986337 used for?

BMS-986337 is not yet approved for any use. It is an investigational small molecule that has completed a single Phase 1 trial in healthy volunteers, where researchers assessed its safety, tolerability, and drug levels when taken by mouth. The intended therapeutic indication has not been disclosed.