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BMS-986256

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Feb 6, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials7
Total Enrollment245

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986256 · 8 trials · 2 indications

Phase 1 8
NCT04941755A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy ParticipantsHealthy Participants
COMPLETED22 Analytics
NCT04493541A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus ErythematosusLupus Erythematosus, Cutaneous
COMPLETED13 Analytics
NCT04470778Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy ParticipantsHealthy Participants
COMPLETED35 Analytics
NCT04269356Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male ParticipantsHealthy Participants
COMPLETED8 Analytics
NCT04016753A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female ParticipantsHealthy Participants
COMPLETED32 Analytics
NCT04039373Effects of BMS-986256 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate MofetilHealthy Participants
COMPLETED15 Analytics
NCT03950960A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy ParticipantsHealthy Participants
COMPLETED15 Analytics
NCT03634995An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy ParticipantsHealthy Participants
COMPLETED118 Analytics
PHASE1COMPLETED
A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
Healthy Participants
NCT0494175522
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PHASE1COMPLETED
A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
Lupus Erythematosus, Cutaneous
NCT0449354113
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PHASE1COMPLETED
Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
Healthy Participants
NCT0447077835
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PHASE1COMPLETED
Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants
Healthy Participants
NCT042693568
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PHASE1COMPLETED
A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants
Healthy Participants
NCT0401675332
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PHASE1COMPLETED
Effects of BMS-986256 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil
Healthy Participants
NCT0403937315
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PHASE1COMPLETED
A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants
Healthy Participants
NCT0395096015
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PHASE1COMPLETED
An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants
Healthy Participants
NCT03634995118
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Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax) of BMS-986256
Up to 19 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) of BMS-986256
Up to 19 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256
Up to 19 days
Incidence of Serious Adverse Events (SAEs)
Up to 24 weeks
Incidence of Adverse Events (AEs)
Up to 20 weeks
Number of laboratory test abnormalities: Hematology
Up to 20 weeks
Number of laboratory test abnormalities: Urinalysis
Up to 20 weeks
Number of laboratory test abnormalities: Clinical Chemistry
Up to 20 weeks
Incidence of clinically significant changes in physical examination findings
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Body temperature
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Respiratory rate
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Blood pressure
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Heart rate
Up to 20 weeks
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters
Up to 20 weeks
Maximum observed plasma concentration (Cmax)
Up to 39 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration AUC(0-T)
Up to 39 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)
Up to 39 days
Maximum observed plasma concentration (Cmax) of [14C] BMS-986256
Up to 49 days
Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256
Up to 49 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)) of [14C] BMS-986256
Up to 49 days
Maximum observed plasma Concentration (Cmax) of Norethindrone (NET)
Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Area under the plasma concentration-time curve over the dosing interval AUC(TAU) of NET
Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Maximum observed plasma Concentration (Cmax) of Ethinyl Estradiol (EE)
Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Area under the plasma concentration-time curve over the dosing interval AUC(TAU)of (EE)
Day 21 of cycle 1 and cycle 2 (each cycle is 28 days)
Mycophenolic Acid (MPA) PK parameter: Maximum observed plasma concentration (Cmax)
days 1-5 and days 26 -30
mycophenolic acid (MPA) PK parameter: area under the concentration-time curve from time zero to the time of the last quantifiable concentration AUC (0-T)
Days 1-5 and Days 26 -30
Mycophenolic Acid (MPA) PK parameter:area under the concentration-time curve from time zero extrapolated to infinite time AUC (INF)
Days 1-5 and days 26 -30
Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) of BMS986256
After single dose on Days 1 and 29
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986256
After single dose on Days 1 and 29
Number of Serious Adverse Events (SAE)
Up to 46 days
Number of deaths
Up to 46 days
Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments
Up to 44 days
Number of Adverse Events (AEs) leading to early discontinuation
Up to 44 days
Maximum concentration (Cmax)
Up to 44 days
Time of maximum concentration (Tmax)
Up to 44 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)]
Up to 44 days
Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)]
Up to 44 days

Secondary Endpoints

Incidence of Adverse Events (AEs)
Up to 45 days
Incidence of Serious Adverse Events (SAEs)
Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Up to 45 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Sequence ABEXPERIMENTAL -
Sequence BAEXPERIMENTAL -
BMS-986256EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
BMS-986256 + FamotidineEXPERIMENTAL -
MonotherapyEXPERIMENTAL -
Treatment ArmEXPERIMENTAL -
BMS-986256 +ItraconazoleEXPERIMENTAL -
Single DoseEXPERIMENTALAscending single doses of BMS-986256
Multiple DoseEXPERIMENTALAscending multiple doses of BMS-986256
Sequential DoseEXPERIMENTALSequential multiple doses of BMS-986256

Interventions

NameTypeDescription
BMS-986256DRUGSpecified dose on specified days
FamotidineDRUGSpecified dose on specified days
BMS-986256 PlaceboOTHERSpecified Dose on Specified Days
Milk of magnesiaDRUGSpecified dose on specified days
LoestrinDRUG1.5 mg Norethindrone and 30ug ethinyl estradiol
Mycophenolate MofetilDRUGspecified dose on specified days
ItraconazoleDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy participants, defined as having no clinically significant deviations from normal in medical history * Weight ≥ 50 kg and body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive, at screening * Normal renal function at screening Exclusion Criteria: * Any signific...

Countries:United StatesGermany
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Frequently asked questions about BMS-986256

What is BMS-986256 used for?

BMS-986256 is an investigational small molecule being studied for use in healthy participants and in patients with active cutaneous lupus erythematosus. It is in Phase 1 clinical development and is not yet approved by the FDA.

Who makes BMS-986256?

BMS-986256 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and drug levels in healthy participants and in patients with cutaneous lupus.

What phase is BMS-986256 in?

BMS-986256 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All seven clinical trials for BMS-986256 are completed, with no active trials currently ongoing.

What clinical trials is BMS-986256 in?

BMS-986256 has completed several Phase 1 trials, including NCT04039373, which studied its effects on the pharmacokinetics of mycophenolate mofetil in healthy participants, and NCT04493541, which assessed safety and drug levels in patients with active cutaneous lupus erythematosus. Other trials include NCT04269356 and NCT04941755.

Is BMS-986256 the same as any other drug?

BMS-986256 is the only name provided for this investigational drug. It is a small molecule being developed by Bristol-Myers Squibb for cutaneous lupus erythematosus and is currently in Phase 1 clinical trials.