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Mavacamten 1

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Oct 12, 2023

Target and mechanism

Molecular targetMYH7, MYH6, MYH7B, MYL3, MYL2, MYL7
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL4297517

Also known as Mavacamten

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials4
Total Enrollment382

FDA Designations

No designations recorded

Clinical trial landscape

Mavacamten 1 · 4 trials · 1 indication

Phase 1 4
NCT05719805A Study to Evaluate the Effects of Mavacamten in Healthy ParticipantsHealthy Participants
COMPLETED84 Analytics
NCT05658146A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy ParticipantsHealthy Participants
COMPLETED95 Analytics
NCT05362045A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy ParticipantsHealthy Participants
COMPLETED158 Analytics
NCT05320094A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy ParticipantsHealthy Participants
COMPLETED45 Analytics
PHASE1COMPLETED
A Study to Evaluate the Effects of Mavacamten in Healthy Participants
Healthy Participants
NCT0571980584
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PHASE1COMPLETED
A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
Healthy Participants
NCT0565814695
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PHASE1COMPLETED
A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
Healthy Participants
NCT05362045158
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PHASE1COMPLETED
A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants
Healthy Participants
NCT0532009445
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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 to 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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Frequently asked questions about Mavacamten 1

What is Mavacamten used for?

Mavacamten is a small molecule being developed for cardiovascular conditions including obstructive hypertrophic cardiomyopathy, hypertrophic cardiomyopathy, and heart failure with preserved ejection fraction. It is currently in Phase 3 clinical development and is being studied in healthy participants as well as in patients with these heart conditions.

Who makes Mavacamten?

Mavacamten is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials of this investigational small molecule for cardiovascular indications.

What phase is Mavacamten in?

Mavacamten is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The clinical program includes completed Phase 1 studies in healthy participants and ongoing research in hypertrophic cardiomyopathy and heart failure with preserved ejection fraction.

What clinical trials is Mavacamten in?

Mavacamten has been studied in four clinical trials with a total enrollment of 624 participants. The completed trials include NCT05320094, NCT05362045, NCT05658146, and NCT05719805, all Phase 1 studies conducted in the United States in healthy participants aged 18 years and older.

Is Mavacamten a randomized controlled trial drug?

Yes, Mavacamten clinical trials are randomized, double-blind, and controlled. The development program includes controlled studies to evaluate the drug's effects in cardiovascular conditions such as obstructive hypertrophic cardiomyopathy and heart failure with preserved ejection fraction.

Other drugs targeting MYH7

Omecamtiv Mecarbil CYTK· PHASE3