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BMS-986209

Phase 1

Undisclosed | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Jan 4, 2022

BMS-986209 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment114

FDA Designations

No designations recorded

BMS-986209 clinical trials

BMS-986209 · 1 trial · 1 indication

Phase 1 1
NCT04154800A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy ParticipantsHealth Participants
COMPLETED114 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants
Health ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Adverse Events (AEs) including bleeding
Up to 18 days
Incidence of serious AEs (SAEs)
Up to 44 days
Incidence of AEs leading to discontinuation
Up to 18 days
Incidence of clinically significant changes in vital signs: Body temperature
Up to 18 days
Incidence of clinically significant changes in vital signs: Respiratory Rate
Up to 18 days
Incidence of clinically significant changes in vital signs: Seated blood pressure
Up to 18 days
Incidence of clinically significant changes in vital signs: Resting pulse rate
Up to 18 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters
Up to 18 days
Incidence of clinically significant changes in clinical laboratory tests: Hematology tests
Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Coagulation tests
Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serum Chemistry tests
Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Urinalysis tests
Up to 16 days
Incidence of clinically significant changes in clinical laboratory tests: Serology tests
Up to 16 days

Secondary Endpoints

Maximum observed plasma concentration (Cmax) of BMS-986209
Up to 18 days
Time of Maximum observed plasma concentration (Tmax) of BMS-986209
Up to 18 days
Terminal plasma half-life (T-Half) of BMS-986209
Up to 18 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A:SADEXPERIMENTALSingle Ascending Dose
Part B: MADEXPERIMENTALMultiple Ascending Dose
Part C: DDIEXPERIMENTALDrug-Drug Interaction
Part A (SAD) PlaceboEXPERIMENTAL -
Part B (MAD) PlaceboEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986209DRUGSpecified Dose on Specified Days
BMS-986209 PlaceboOTHERSpecified Dose on Specified Days
ItraconazoleDRUGSpecified Dose on Specified Days
DiltiazemDRUGSpecified Dose on Specified Days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Healthy male and female participants (not of childbearing potential) as determined by no deviation considered significant by the investigator from normal in...

Countries:United States
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Frequently asked questions about BMS-986209

What is BMS-986209?

BMS-986209 is an investigational small molecule drug developed by Bristol-Myers Squibb Company. It has been studied in a Phase 1 clinical trial in healthy adult participants. The specific disease indications being explored for BMS-986209 have not been publicly disclosed.

Who is developing BMS-986209?

BMS-986209 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 clinical trial evaluating the drug in healthy participants.

What phase is BMS-986209 in?

BMS-986209 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is BMS-986209 in?

BMS-986209 has been evaluated in one clinical trial, NCT04154800, titled A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants. The Phase 1 trial was completed and enrolled 114 healthy adult participants in the United States.

How was the BMS-986209 Phase 1 trial designed?

The Phase 1 trial NCT04154800 was a randomized, double-blind, controlled study of single and multiple doses of BMS-986209 in 114 healthy adult participants of all sexes, aged 18 years and older. It was conducted in the United States and has been completed.