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BMS-986165 formulation 1

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Nov 11, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986165 formulation 1 · 1 trial · 1 indication

Phase 1 1
NCT04305899A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult ParticipantsHealthy Participants
COMPLETED40 Analytics
PHASE1COMPLETED
A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult Participants
Healthy Participants
NCT0430589940
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Study Endpoints

Primary Endpoints

Maximum concentration (Cmax) in plasma for BMS-986165
Up to 26 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165
Up to 26 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) in plasma for BMS-986165
Up to 26 days

Secondary Endpoints

Incidence of Adverse Events (AEs)
Up to 26 days
Incidence of Serious Adverse Events (SAEs)
Up to 98 days
Incidence of clinically significant changes in physical examination findings
Up to 68 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Group 1EXPERIMENTAL -
Treatment Group 2EXPERIMENTAL -
Treatment Group 3EXPERIMENTAL -
Treatment Group 4EXPERIMENTAL -
Treatment Group 5EXPERIMENTAL -
Treatment Group 6EXPERIMENTAL -
Treatment Group 7EXPERIMENTAL -
Treatment Group 8EXPERIMENTAL -
Treatment Group 9EXPERIMENTAL -
Treatment Group 10EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986165 Tablet formulation 1DRUGSpecified dose on specified days
BMS-986165 Tablet formulation 2DRUGSpecified dose on specified days
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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: * Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laborator...

Countries:United States
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Frequently asked questions about BMS-986165 formulation 1

What is BMS-986165 formulation 1 used for?

BMS-986165 formulation 1 is an investigational small molecule being studied in healthy participants. It is being evaluated in a Phase 1 clinical trial to compare the taste and blood plasma levels of BMS-986165 when taken as different formulations. The study is completed and enrolled 40 participants in the United States.

Who makes BMS-986165 formulation 1?

BMS-986165 formulation 1 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company conducted a Phase 1 clinical trial to evaluate this formulation in healthy adult participants.

What phase is BMS-986165 formulation 1 in?

BMS-986165 formulation 1 is in Phase 1 clinical development. The single trial for this formulation has been completed, and it is not yet approved by regulatory authorities. It remains an investigational drug in clinical development.

What clinical trials is BMS-986165 formulation 1 in?

BMS-986165 formulation 1 was studied in clinical trial NCT04305899, titled "A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult Participants." This Phase 1 trial was completed and enrolled 40 participants in the United States.

Is BMS-986165 formulation 1 the same as BMS-986165?

BMS-986165 formulation 1 is a specific formulation of the drug BMS-986165. The clinical trial NCT04305899 was designed to compare the taste and blood plasma levels of BMS-986165 when taken as different formulations, indicating that formulation 1 is one of several versions being tested.