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BMS-984923

Phase 1

Drug Drug Interaction (DDI) | Small molecule | Other |cbdMD, Inc.|Last Updated: Feb 7, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

BMS-984923 · 1 trial · 1 indication

Phase 1 1
NCT06632990A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe SubstratesDrug Drug Interaction (DDI)
ACTIVE NOT_RECRUITING36 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates
Drug Drug Interaction (DDI)Unlock trial analytics

Study Endpoints

Primary Endpoints

Area under the curve for the first and last 96 hours of dosing (AUC96h) as determined by PK modeling
24 days

Total plasma concentration of caffeine as determined by pharmacokinetic modeling

Area under the curve for the last 96 hours of dosing (AUC96h)
last 96 hours

Total plasma concentration of BMS-984923 as determined by pharmacokinetic modeling

Trough plasma drug concentration at steady state
21 days

plasma concentration of BMS-984923 as determined by pharmacokinetic modeling

Secondary Endpoints

Incidence of treatment-emergent adverse events (TEAEs) Safety
30 days
Incidence of clinically significant lab abnormalities
30 days
Incidence of clinically significant changes in safety assessments vital signs, physical exam, electrocardiogram
30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
50 mg Active once dailyEXPERIMENTAL -
50 mg Active twice dailyEXPERIMENTAL -
100 mg Active twice dailyEXPERIMENTAL -
Reference drugs cocktailEXPERIMENTALmidazolam, caffeine and dextromethorphan will be administered orally

Interventions

NameTypeDescription
BMS-984923DRUGoral capsules once or twice daily
MidazolamDRUGmidazolam, oral, 2mg administered before study drug and after study drug
CaffeineDRUGCaffeine, oral, 100mg administered before study drug and after study drug
dextromethorphanDRUGdextromethorphan, oral, 30mg administered before study drug and after study drug
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Men or women between the ages of 18 and 50 years, inclusive. * No history of cognitive impairment. * Capable of providing written informed consent and willing to comply with all study requirements and procedures. * Female participants, if of childbearing potential, must be non...

Countries:United States
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Frequently asked questions about BMS-984923

What is BMS-984923 used for?

BMS-984923 is an investigational small molecule being studied for its potential to alter the systemic exposure of three orally administered probe substrates. It is currently in a Phase 1 clinical trial focused on drug-drug interactions (DDI) in healthy volunteers in the United States.

Who makes BMS-984923?

BMS-984923 is being developed by cbdMD, Inc., a company traded under the ticker YCBD. The drug is currently in Phase 1 clinical development for drug-drug interaction studies.

What phase is BMS-984923 in?

BMS-984923 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants.

What clinical trials is BMS-984923 in?

BMS-984923 is being evaluated in one Phase 1 clinical trial, NCT06632990, titled "A Study Evaluating the Potential of BMS-984923 to Alter the Systemic Exposure of Three Orally Administered Probe Substrates." The trial is active but not recruiting, with an enrollment of 36 healthy volunteers in the United States.

Is BMS-984923 the same as any other drug?

No alternative names for BMS-984923 have been disclosed. The drug is identified solely by its code name BMS-984923 in the available clinical trial information.