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Mavacamten 1

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Oct 12, 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
RandomizedCONTROLLEDBiomarker
Total Trials4
Total Enrollment382
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05719805A Study to Evaluate the Effects of Mavacamten in Healthy ParticipantsPHASE1 COMPLETED 84 — — Feb 20, 2023Jul 25, 2023Oct 12, 20232 United States
NCT05658146A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy ParticipantsPHASE1 COMPLETED 95 — — Jan 6, 2023Jul 5, 2023Oct 11, 20233 United States
NCT05362045A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy ParticipantsPHASE1 COMPLETED 158 — — May 16, 2022Aug 19, 2022Nov 21, 20224 United States
NCT05320094A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy ParticipantsPHASE1 COMPLETED 45 — — Apr 15, 2022Sep 11, 2022Nov 8, 20221 United States
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax)
Predose and post-dose up to Day 80
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Predose and post-dose up to Day 80
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
Predose and post-dose up to Day 80
Maximum Observed Serum Concentration (Cmax)
From Day 1 up to Day 35±2 of each period
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
From Day 1 up to Day 35±2 of each period
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
From Day 1 up to Day 35±2 of each period
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))
Up to approximately 1 month
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Up to approximately 1 month
Secondary Endpoints
Time of maximum observed plasma concentration (Tmax)
Predose and post-dose up to Day 80
Terminal Half-life (T-Half)
Predose and post-dose up to Day 80
Number of Participants with Adverse Events (AEs)
Up to Day 80
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Mavacamten Dose 1EXPERIMENTAL -
Mavacamten Dose 2EXPERIMENTAL -
Sequence 1EXPERIMENTAL -
Sequence 2EXPERIMENTAL -
Sequence 3EXPERIMENTAL -
Sequence 4EXPERIMENTAL -
Sequence 5EXPERIMENTAL -
Sequence 6EXPERIMENTAL -
Mavacamten- Dose AEXPERIMENTAL -
Mavacamten- Dose BEXPERIMENTAL -
MavacamtenEXPERIMENTAL -
Mavacamten and activated charcoal with sorbitol - Dose AEXPERIMENTAL -
Mavacamten and activated charcoal with sorbitol - Dose BEXPERIMENTAL -
Interventions
NameTypeDescription
MavacamtenDRUGSpecified dose on specified days
Mavacamten Capsule 1DRUGSpecified dose on specified days
Mavacamten Capsule 2DRUGSpecified dose on specified days
Mavacamten Capsule 3DRUGSpecified dose on specified days
Activated Charcoal with SorbitolDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Body mass index between 18 and 32 kg/m\^2, inclusive, at the screening visit. * Healthy, as determined by physical examination, vital signs, 12-lead ECGs, and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the scree...

Countries:United States
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