A Study to Evaluate the Effects of Mavacamten in Healthy Participants

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.

Official Title
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An Open-label, Randomized, Single-dose, 2-way Crossover Study to Establish Bioequivalence of 1 × 15-mg Mavacamten Capsule to 3 × 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, 12-lead ECGs, and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1. Participants with values outside of the normal range may be included if the values are not considered, by the investigator, to be clinically significant unless such values are explicitly excluded. Cytochrome P450 (CYP2C19) normal (*1/*1), rapid (*1/*17), or ultra-rapid (*17/*17) metabolizer, as determined by genotyping during screening. Exclusion Criteria: Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, LV systolic dysfunction, coronary heart disease; current, history, or family history of HCM; or evidence of prior myocardial infarction based on ECGs. Current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, Crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting. Any gastrointestinal surgery (other than appendectomy) that, in the opinion of the investigator, could impact the absorption of study intervention. Note: 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mavacamten Dose 1<br> | Drug: Mavacamten<br>* Specified dose on specified days<br>* Other names: MYK-461;|
| Experimental: Mavacamten Dose 2<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) |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of Participants with Serious AEs (SAEs) |  | Up to Day 80 | 
| Number of Participants with Vital Sign Abnormalities |  | Up to Day 80 | 
| Number of Participants with Electrocardiogram (ECG) Abnormalities |  | Up to Day 80 | 
| Number of Participants with Physical Examination Abnormalities |  | Up to Day 80 | 
| Number of Participants with Clinical Laboratory Abnormalities |  | Up to Day 80 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertrophic cardiomyopathy (HCM), Left ventricular (LV) hypertrophy, Bioequivalence, Left Ventricular Outflow Tract Obstruction, Heart diseases, Cardiovascular diseases