A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.

Official Title
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Bioequivalence Study of a Single Dose of 15-mg Mavacamten Capsule Versus a Single Dose of 3 x 5-mg Mavacamten Capsules in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Mavacamten


Participation Criteria
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Eligibility Criteria
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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, electrocardiograms (ECGs), and clinical laboratory assessments within the normal range at the screening visit and/or on Day -1 Exclusion Criteria: Current or recent (within 3 months of study intervention administration) gastrointestinal disease History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mavacamten- Dose A<br> | Drug: Mavacamten<br>* Specified dose on specified days<br>* Other names: MYK-461;|
| Experimental: Mavacamten- Dose B<br> | Drug: Mavacamten<br>* Specified dose on specified days<br>* Other names: MYK-461;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to approximately 1 month | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maximum observed plasma concentration (Tmax) |  | Up to approximately 1 month | 
| Terminal half-life (T-HALF) |  | Up to approximately 1 month | 
| Number of participants with adverse events (AEs) |  | Up to approximately 1 month | 
| Number of participants with serious adverse events (SAEs) |  | Up to approximately 1 month | 
| Number of participants with vital sign abnormalities exceeding predefined thresholds |  | Up to approximately 1 month | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to approximately 1 month | 
| Number of participants with physical exam abnormalities |  | Up to approximately 1 month | 
| Number of participants with clinical laboratory evaluation abnormalities |  | Up to approximately 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mavacamten, Healthy Participants, Bioequivalence, Hypertrophic Cardiomyopathy