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BMS-986308

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986308 · 1 trial · 1 indication

Phase 1 1
NCT04763226A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy ParticipantsHealthy Participants
COMPLETED46 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants
Healthy Participants
NCT0476322646
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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 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: * 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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Frequently asked questions about BMS-986308

What is BMS-986308 used for?

BMS-986308 is an investigational small molecule being studied in healthy participants. It is being evaluated for safety, tolerability, drug levels, and drug effects. The drug is in Phase 1 clinical development and is not yet approved for any medical use.

Who makes BMS-986308?

BMS-986308 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy participants.

What phase is BMS-986308 in?

BMS-986308 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A Phase 1 study has been completed to evaluate its safety, tolerability, drug levels, and drug effects in healthy participants.

What clinical trials is BMS-986308 in?

BMS-986308 has one completed clinical trial, NCT04763226, titled 'A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants.' This Phase 1 study enrolled 46 participants in the United States and was completed.

Is BMS-986308 FDA approved?

BMS-986308 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial evaluated the drug in healthy participants to assess safety, tolerability, drug levels, and drug effects, but approval has not been granted.