Recent Updates
Recently added Catalysts

BMS-986371

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Feb 8, 2023

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986371 · 1 trial · 1 indication

Phase 1 1
NCT05445440A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of SulfasalazineHealthy Participants
COMPLETED30 Analytics
PHASE1COMPLETED
A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine
Healthy Participants
NCT0544544030
Unlock trial analytics

Study Endpoints

Primary Endpoints

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Up to 22 days

Part 1

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 22 days

Part 1

Maximum observed plasma concentration (Cmax)
Up to 22 days

Part 1

Secondary Endpoints

AUC(0-T)
Up to 22 days
AUC(INF)
Up to 22 days
Cmax
Up to 22 days
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -

Interventions

NameTypeDescription
MethotrexateDRUGSpecified dose on specified days
LeucovorinDRUGSpecified dose on specified days
BMS-986371DRUGSpecified dose on specified days
SulfasalazineDRUGSpecified dose on specified days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol * Body mass index of 18 to 32 kg...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about BMS-986371

What is BMS-986371 used for?

BMS-986371 is an investigational small molecule being studied in healthy participants. It is being evaluated in a clinical trial to assess its effects on the drug levels of methotrexate in the presence and absence of sulfasalazine. The drug is in Phase 1 clinical development and is not approved by the FDA.

Who makes BMS-986371?

BMS-986371 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting a Phase 1 clinical trial to evaluate the drug's effects on methotrexate levels in healthy participants.

What phase is BMS-986371 in?

BMS-986371 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial, NCT05445440, has been completed and enrolled 30 healthy male participants in the United States.

What clinical trials is BMS-986371 in?

BMS-986371 has one completed Phase 1 clinical trial, NCT05445440, titled "A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine." The trial enrolled 30 healthy male participants aged 18 years and older in the United States.

Is BMS-986371 FDA approved?

BMS-986371 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial, NCT05445440, studied the drug's effects on methotrexate levels in healthy participants, but the drug has not been approved for any use.