Recent Updates
Recently added Catalysts

Prototype BMS-986165

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Oct 6, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

Prototype BMS-986165 · 1 trial · 1 indication

Phase 1 1
NCT04536961A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy ParticipantsHealthy Volunteers
COMPLETED56 Analytics
PHASE1COMPLETED
A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants
Healthy Volunteers
NCT0453696156
Unlock trial analytics

Study Endpoints

Primary Endpoints

Maximum observed plasma concentration (Cmax) of BMS-986165
Day 1 and Day 7
Time of maximum observed plasma concentration (Tmax) of BMS-986165
Day 1 and Day 7
Area under the plasma concentration-time curve from time zero to t (AUC (0-t)) of BMS-986165
Day 1 and Day 7

Part A, B, C

Secondary Endpoints

Incidence of Nonserious Adverse Events (AEs)
Up to approximately 60 days (for Parts A & C), approximately 69 days (for Part B)
Incidence of Serious Adverse Events (AEs)
Up to approximately 83 days (for Parts A & C), approximately 92 days (for Part B)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Reference TreatmentEXPERIMENTAL -
Part A PrototypeEXPERIMENTAL -
Part C Reference TreatmentEXPERIMENTAL -
Part C: PrototypeEXPERIMENTAL -
Part B: Treatment 1EXPERIMENTAL -
Part B: Treatment 2EXPERIMENTAL -
Part B: Treatment 3EXPERIMENTAL -
Part B: Treatment 4EXPERIMENTAL -
Part B: Treatment 5EXPERIMENTAL -

Interventions

NameTypeDescription
Reference Treatment- BMS-986165-01DRUGSpecified dose on specified days
Prototype BMS-986165DRUGSpecified dose on specified days
FamotidineDRUGSpecified dose on specified days
AlcoholOTHERSpecified quantity on specified days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations. ...

Countries:United Kingdom
Unlock Eligibility Criteria

Frequently asked questions about Prototype BMS-986165

What is Prototype BMS-986165?

Prototype BMS-986165 is an investigational small molecule being developed by Bristol-Myers Squibb. It is currently in Phase 1 clinical development, studied in healthy volunteers. The drug is being evaluated for its pharmacokinetic properties, specifically how drug levels behave when taken as various solid tablet prototypes.

What is Prototype BMS-986165 used for?

Prototype BMS-986165 is being studied in healthy volunteers to evaluate drug levels when taken as various solid tablet prototypes. It is an investigational small molecule in Phase 1 clinical development. The study aims to assess how different tablet formulations affect the drug's absorption and exposure in the body.

Who makes Prototype BMS-986165?

Prototype BMS-986165 is 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 to evaluate the drug's pharmacokinetic profile in healthy volunteers.

What phase is Prototype BMS-986165 in?

Prototype BMS-986165 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing clinical program includes one completed Phase 1 trial that enrolled 56 healthy volunteers in the United Kingdom.

What clinical trials is Prototype BMS-986165 in?

Prototype BMS-986165 has one completed clinical trial, NCT04536961, titled 'A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants.' This Phase 1 study enrolled 56 healthy volunteers in the United Kingdom and evaluated drug levels from different tablet formulations.

Is Prototype BMS-986165 the same as BMS-986165?

Prototype BMS-986165 refers to a specific tablet formulation of the drug BMS-986165. The clinical trial NCT04536961 evaluates drug levels of BMS-986165 when administered as various solid tablet prototypes. The prototype designation indicates the formulation being tested, not a different drug entity.