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BMS-986189

Phase 1

Severe Sepsis | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Feb 7, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986189 · 1 trial · 1 indication

Phase 1 1
NCT02739373Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy SubjectsSevere Sepsis
COMPLETED76 Analytics
PHASE1COMPLETED
Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy Subjects
Severe SepsisUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum observed concentration (Cmax)
Day 1 to Day 30
Time of maximum observed concentration (Tmax)
Day 1 to Day 30
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(O-T))
Day 1 to Day 30
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Day 1 to Day 30
Half Life (T-HALF)
Day 1 to Day 30
Total Body Clearance (CLT/F)
Day 1 to Day 30
Apparent volume of distribution at steady state (Vss/F)
Day 1 to Day 30
Deaths leading to discontinuation
Day 1 to Day 30
Adverse events (AEs) leading to discontinuation
Day 1 to Day 30
Serious adverse events (SAEs) leading to discontinuation
Day 1 to Day 30
Lab abnormalities leading to discontinuation
Day 1 to Day 30
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
BMS-986189EXPERIMENTALSpecified Dose on Specified Day
PlaceboPLACEBO_COMPARATORSpecified Dose on Specified Day

Interventions

NameTypeDescription
BMS-986189DRUG -
PlaceboOTHER -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy, males and females, 18 to 55 years of age, inclusive * Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive * Women of childbearing potential (WOCBP) must have nega...

Countries:United States
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Frequently asked questions about BMS-986189

What is BMS-986189 used for?

BMS-986189 is an investigational small molecule being developed for severe sepsis, a life-threatening condition caused by an overwhelming immune response to infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes BMS-986189?

BMS-986189 is being developed by Bristol-Myers Squibb Company, a global biopharmaceutical company. The company's stock is traded under the ticker symbol BMY on the New York Stock Exchange.

What phase is BMS-986189 in?

BMS-986189 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received regulatory approval and is not yet available for clinical use outside of clinical trials.

What clinical trials is BMS-986189 in?

BMS-986189 has one completed Phase 1 clinical trial, identified as NCT02739373. This study evaluated the pharmacokinetics, safety, tolerability, and pharmacodynamics of BMS-986189 in healthy subjects in the United States, with a total enrollment of 76 participants.

Is BMS-986189 FDA approved?

No, BMS-986189 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on healthy subjects to assess safety and pharmacokinetics, and further clinical development would be required before any regulatory approval could be considered.