Recent Updates
Recently added Catalysts

BMS-986209

Phase 1

Health Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jan 4, 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment114

FDA Designations

No designations recorded

Clinical trial landscape

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 Participants
NCT04154800114
Unlock 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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about BMS-986209

What is BMS-986209 used for?

BMS-986209 is an investigational small molecule being studied for use in healthy participants. It is being evaluated in a Phase 1 clinical trial to assess its safety, tolerability, drug levels, and drug effects after single and multiple doses. The drug is not approved for any condition and remains in clinical development.

What does BMS-986209 target?

BMS-986209 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied in healthy participants to evaluate its safety, tolerability, and pharmacokinetics, which are typical early-stage investigations before any target-specific efficacy studies are conducted.

Who makes BMS-986209?

BMS-986209 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 a Phase 1 clinical trial to evaluate the drug's safety and tolerability in healthy participants.

What phase is BMS-986209 in?

BMS-986209 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A Phase 1 study has been completed, evaluating the safety, tolerability, drug levels, and drug effects of single and multiple doses in healthy participants.

What clinical trials is BMS-986209 in?

BMS-986209 has one completed clinical trial, identified as NCT04154800. This Phase 1 study, titled 'A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants,' enrolled 114 participants in the United States. The trial was randomized, double-blind, and controlled.

Is BMS-986209 the same as any other drug?

BMS-986209 is the only name provided for this investigational drug. No alternative names or aliases have been disclosed. The drug is being developed by Bristol-Myers Squibb and is currently in Phase 1 clinical trials for healthy participants.