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MYK-224

Phase 1

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

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 Trials2
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05686096A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435PHASE1 COMPLETED 7 — — Jan 16, 2023Apr 8, 2023May 25, 20231 United States
NCT05405543A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese ParticipantsPHASE1 COMPLETED 36 — — Jul 12, 2022Dec 9, 2022Jan 13, 20231 United States
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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
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 -
Interventions
NameTypeDescription
MYK-224DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 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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