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BMS-986196

Phase 1

Healthy Female Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Nov 13, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986196 · 4 trials · 4 indications

Phase 1 4
NCT05981963A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male ParticipantsHealthy Male Volunteers
COMPLETED8 Analytics
NCT05891262A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female ParticipantsHealthy Female Volunteers
COMPLETED15 Analytics
NCT05852769A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy ParticipantsHealthy Volunteers
COMPLETED18 Analytics
NCT04882150A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy ParticipantsHealthy Participants
COMPLETED102 Analytics
PHASE1COMPLETED
A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants
Healthy Male Volunteers
NCT059819638
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PHASE1COMPLETED
A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants
Healthy Female Volunteers
NCT0589126215
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PHASE1COMPLETED
A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
Healthy Volunteers
NCT0585276918
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PHASE1COMPLETED
A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants
Healthy Participants
NCT04882150102
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Study Endpoints

Primary Endpoints

Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax)
Up to Day 15
TRA: Time of Cmax (Tmax)
Up to Day 15
TRA: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Up to Day 15
TRA: Amount of radioactivity recovered in urine (UR)
Up to Day 15
TRA: Amount of radioactivity recovered in feces (FR)
Up to Day 15
TRA: Amount of radioactivity recovered in bile (BR)
Up to 14 hours post dose
TRA: Percent of administered dose recovered in urine (%UR)
Up to Day 15
TRA: Percent of administered dose recovered in feces (%FR)
Up to Day 15
TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total)
Up to Day 15
Maximum observed plasma concentration (Cmax)
At Day 1 and Day 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
At Day 1 and Day 20
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
At Day 1 and Day 20
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 26 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Up to 26 days
Incidence of Adverse Events (AEs)
Up to 24 days
Severity of AEs
Up to 24 days
Causality of AEs
Up to 24 days
Incidence of Serious Adverse Events (SAEs)
Up to 59 days
Severity of SAEs
Up to 59 days
Causality of SAEs
Up to 59 days
Incidence of clinically significant changes in vital signs: Body temperature
Up to 24 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Up to 24 days
Incidence of clinically significant changes in vital signs: Blood pressure
Up to 24 days
Incidence of clinically significant changes in vital signs: Heart rate
Up to 24 days
Incidence of clinically significant changes in weight
Up to 24 days
Incidence of clinically significant changes in physical examination
Up to 24 days
Incidence of clinically significant changes in ECG parameters: QT interval
Up to 24 days
Incidence of clinically significant changes in ECG parameters: HR
Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Coagulation tests
Up to 24 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Up to 24 days

Secondary Endpoints

Cmax
Up to Day 15
Tmax
Up to Day 15
AUC (0-T)
Up to Day 15
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
[14C]-BMS-986196EXPERIMENTAL -
BMS-986196 and LoestrinEXPERIMENTAL -
BMS-986196 and/or Cocktail Probe Substrate DrugsEXPERIMENTAL -
Part A: SADEXPERIMENTALSAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo.
Part B: MADEXPERIMENTALMAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo.
Part C: FE/Formul.EXPERIMENTALFE/Formul. = food and formulation effects and relative absorption. Participants will receive two formulations of BMS-986196 (solution and suspension), each formulation with and without food.

Interventions

NameTypeDescription
[14C]-BMS-986196DRUGSpecified dose on specified days
BMS-986196DRUGSpecified dose on specified days
LoestrinDRUGSpecified dose on specified days
CaffeineDRUGSpecified dose on specified days
MontelukastDRUGSpecified dose on specified days
FlurbiprofenDRUGSpecified dose on specified days
OmeprazoleDRUGSpecified dose on specified days
MidazolamDRUGSpecified dose on specified days
DigoxinDRUGSpecified dose on specified days
PravastatinDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male participants without clinically significant deviation from normal in medical history, electrocardiogram (ECG), clinical laboratory determinations, and Day -1 physical examination. * Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m\^2), inclusive, and t...

Countries:United States
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Frequently asked questions about BMS-986196

What is BMS-986196 used for?

BMS-986196 is an investigational small molecule being studied in healthy volunteers, including healthy female, healthy male, and healthy participants. It is in Phase 1 clinical development, with trials evaluating its safety, drug levels, drug effects, and interactions in healthy individuals.

Who makes BMS-986196?

BMS-986196 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy participants.

What phase is BMS-986196 in?

BMS-986196 is in Phase 1 clinical development. It is an investigational drug, not yet approved, and is being studied in healthy volunteers to assess safety, drug levels, and drug effects. All four Phase 1 trials have been completed.

What clinical trials is BMS-986196 in?

BMS-986196 has been studied in four completed Phase 1 trials: NCT04882150 (safety, drug levels, and food/formulation effects), NCT05852769 (drug-drug interaction potential), NCT05891262 (interaction with oral contraceptives in healthy females), and NCT05981963 (drug levels and removal in healthy males).

Is BMS-986196 FDA approved?

BMS-986196 is not FDA approved. It is an investigational small molecule in Phase 1 clinical development, studied only in healthy volunteers. Its safety and efficacy have not been established, and it remains under clinical investigation by Bristol-Myers Squibb.