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MYK-224

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: May 25, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

MYK-224 · 3 trials · 2 indications

Phase 1 3
NCT05686096A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435Healthy Volunteers
COMPLETED7 Analytics
NCT05405543A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese ParticipantsHealthy Volunteers
COMPLETED36 Analytics
NCT05304533A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy ParticipantsHealthy Participants
COMPLETED45 Analytics
PHASE1COMPLETED
A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435
Healthy Volunteers
NCT056860967
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PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese Participants
Healthy Volunteers
NCT0540554336
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PHASE1COMPLETED
A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants
Healthy Participants
NCT0530453345
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Study Endpoints

Primary Endpoints

Maximum observed concentration (Cmax)
Up to 45 days
Time to maximum observed concentration (Tmax)
Up to 45 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Up to 45 days
Maximum observed plasma concentration (Cmax)
Up to 72 days
Time of maximum observed concentration (Tmax)
Up to 72 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Up to 72 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 36 days

Secondary Endpoints

Metabolite profiling of BMS-986435 in plasma, urine, and feces
Up to 45 days
Number of participants with adverse events (AEs)
Up to 45 days
Number of participants with clinical laboratory abnormalities
Up to 45 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MYK-224EXPERIMENTAL -
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3EXPERIMENTAL -
Arm 4EXPERIMENTAL -
Arm 1: MYK-224EXPERIMENTAL -
Arm 2: MYK-224 + ItraconazoleEXPERIMENTAL -
Arm 3: MYK-224 + VerapamilEXPERIMENTAL -

Interventions

NameTypeDescription
MYK-224DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
ItraconazoleDRUGSpecified dose on specified days
VerapamilDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Body mass index between 18 and 32 kg/m\^2, inclusive, at screening. - Healthy male participants as determined by the investigator and sponsor. * Adequate acoustic windows to enable accurate transthoracic echocardiogram (TTE) assessment of parameters of left ventricular (LV...

Countries:United States
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Frequently asked questions about MYK-224

What is MYK-224 used for?

MYK-224 is an investigational small molecule being studied in healthy participants and healthy volunteers. It is currently in Phase 1 clinical development, with completed trials assessing drug interactions, safety, tolerability, and drug levels. It is not approved for any condition and remains under investigation.

Who makes MYK-224?

MYK-224 is being 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 safety and pharmacokinetics in healthy participants.

What phase is MYK-224 in?

MYK-224 is in Phase 1 clinical development. All of its clinical trials have been completed, with no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is MYK-224 in?

MYK-224 has been studied in three completed Phase 1 trials. NCT05304533 assessed drug interactions with itraconazole and verapamil in 45 healthy participants. NCT05405543 evaluated safety, tolerability, and drug levels in 36 healthy Japanese participants. NCT05686096 examined absorption, metabolism, and excretion in 7 healthy male volunteers.

Is MYK-224 the same as BMS-986435?

Yes, MYK-224 is also known as BMS-986435. One of its clinical trials, NCT05686096, is titled 'A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435,' confirming that the two names refer to the same investigational drug.