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BMS-986308

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Apr 27, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04763226A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy ParticipantsPHASE1 COMPLETED 46 — — Apr 14, 2021Feb 27, 2022Apr 27, 20221 United States
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events (AEs)
Up to 19 days

Part B

Incidence of serious adverse events (SAEs)
Up to 19 days

Part B

Incidence of death
Up to 19 days

Part B

Incidence of adverse events (AEs) leading to discontinuation
Up to 19 days

Part B

Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Up to 19 days

Part B

Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Up to 19 days

Part B

Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Up to 19 days

Part B

Incidence of clinically significant changes in vital signs: Respiratory rate
Up to 19 days

Part B

Incidence of clinically significant changes in vital signs: Supine blood pressure
Up to 19 days

Part B

Incidence of clinically significant changes in vital signs: Heart rate
Up to 19 days

Part B

Incidence of clinically significant changes in vital signs: Orthostatic hypotension measurements performed as per clinical research unit's standard operating procedure
Up to 19 days

Part B

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Up to 19 days

Part B PR interval is the time from the onset of the P wave to the start of the QRS complex

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS
Up to 19 days

Part B QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Up to 19 days

Part B The QT interval is the time from the start of the Q wave to the end of the T wave

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
Up to 19 days

Part B QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave

Incidence of clinically significant changes in cardiac telemetry
Up to 19 days

Part B

Incidence of clinically significant changes in physical examination findings
Up to 19 days

Part B

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A FurosemideEXPERIMENTAL -
Part B (SAD)EXPERIMENTALSingle Ascending Dose (SAD)
Interventions
NameTypeDescription
BMS-986308DRUGSpecified dose on specified days
Placebo (for BMS-986308)OTHERSpecified dose on specified days
FurosemideDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Must be in good health, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs)...

Countries:United States
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