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BMS-986331

Phase 1

Undisclosed | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Oct 20, 2022

BMS-986331 development status

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

BMS-986331 clinical trials

BMS-986331 · 1 trial · 1 indication

Phase 1 1
NCT04444050Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy ParticipantsHealthy Participants
COMPLETED48 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)
Up to 13 months
Number of participants with clinical laboratory abnormalities
Up to 46 days
Number of participants with vital sign abnormalities
Up to 46 days
Number of participants with electrocardiogram (ECG) abnormalities
Up to 46 days

Secondary Endpoints

Maximum plasma concentration (Cmax)
Up to 17 days
Time to reach Cmax in plasma (Tmax)
Up to 17 days
Area under the plasma concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed [AUC(0-T)]
Up to 17 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part 1 Single Ascending Dose (SAD): Panel 1EXPERIMENTAL -
Part 1 SAD: Panel 2EXPERIMENTAL -
Part 1 SAD: Panel 3EXPERIMENTAL -
Part 1 SAD: Panel 4EXPERIMENTAL -
Part 1 SAD: Panel 5EXPERIMENTAL -
Part 1 SAD: Panel 6EXPERIMENTAL -
Part 1 SAD: Optional Split-dose PanelEXPERIMENTAL -
Part 2 Multiple Ascending Dose (MAD): Panel 1EXPERIMENTAL -
Part 2 MAD: Panel 2EXPERIMENTAL -
Part 2 MAD: Panel 3EXPERIMENTAL -
Part 2 MAD: Panel 4EXPERIMENTAL -
Part 2 MAD: Optional (to be determined) PanelEXPERIMENTAL -
Part 3 MAD in Japanese Participants (J-MAD): Panel 1EXPERIMENTAL -
Part 3 J-MAD: Panel 2EXPERIMENTAL -
Part 3 J-MAD: Panel 3EXPERIMENTAL -
Part 3 J-MAD: Optional (to be determined) PanelEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986331DRUGSpecified dose on specified days
Placebo, Matching BMS-986331OTHERSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * No clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations * A body mass index of 18 - 32 kg/m2, inclusive * Women and men must agree to follow specific methods of contraception, if applicable For J...

Countries:United States
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Frequently asked questions about BMS-986331

What is BMS-986331?

BMS-986331 is an investigational small molecule being developed by Bristol-Myers Squibb Company. It has been studied in a Phase 1 clinical trial in healthy adult participants. The specific disease or condition it is intended to treat has not been publicly disclosed.

Who makes BMS-986331?

Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, is the developer of BMS-986331. The company sponsored the Phase 1 trial evaluating the compound in healthy participants.

What phase is BMS-986331 in?

BMS-986331 is in Phase 1 clinical 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-986331 in?

BMS-986331 has been evaluated in one clinical trial, NCT04444050, titled a Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants. The Phase 1 trial enrolled 48 participants in the United States and is completed.

What was the design of the BMS-986331 Phase 1 trial?

The Phase 1 trial NCT04444050 was a randomized, double-blind, controlled study in healthy adult participants aged 18 years and older. It enrolled 48 participants across sites in the United States and assessed safety, tolerability, drug levels, and drug effects.