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BMS-986308

Phase 1

Undisclosed | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Apr 27, 2022

BMS-986308 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2021

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

BMS-986308 clinical trials

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?

BMS-986308 is an investigational small molecule being developed by Bristol-Myers Squibb Company (ticker: BMY). It has been studied in a Phase 1 clinical trial in healthy participants. The specific therapeutic indication for BMS-986308 has not been disclosed.

Who is developing BMS-986308?

BMS-986308 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company sponsored the Phase 1 trial of BMS-986308 in healthy participants.

What phase is BMS-986308 in?

BMS-986308 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.

What clinical trials is BMS-986308 in?

BMS-986308 has been evaluated in one completed Phase 1 trial, NCT04763226, titled "A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants." The trial enrolled 46 healthy volunteers in the United States and was randomized, double-blind, and controlled.

What is BMS-986308 used for?

BMS-986308 is not approved for any indication. It has been studied only in healthy participants in a Phase 1 trial, and its intended therapeutic use has not been disclosed.

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