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BMS-986337

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Feb 25, 2022

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

Clinical trial landscape

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 used for?

BMS-986337 is an investigational small molecule being studied in healthy volunteers. It is being evaluated for safety, tolerability, and drug levels when taken by mouth. The drug is not approved for any condition and is in early clinical development.

Who makes BMS-986337?

BMS-986337 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy participants.

What phase is BMS-986337 in?

BMS-986337 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.

What clinical trials is BMS-986337 in?

BMS-986337 has one completed Phase 1 clinical trial, identified as NCT04550195. The study evaluated the safety, tolerability, and drug levels of BMS-986337 when taken by mouth by healthy participants. The trial was conducted in the Netherlands with 26 participants aged 21 years and older.

Is BMS-986337 FDA approved?

BMS-986337 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on safety and tolerability in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory review.