A Study to Assess 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 assess the effects on the single-dose drug levels of mavacamten in healthy participants.

Official Title
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An Open-label, Randomized, Single-dose, Three-way Crossover Study to Establish Bioequivalence of 5 mg Mavacamten Capsule 1 and 5 × 1 mg Mavacamten Capsule 2 to 5 mg Mavacamten Capsule 2 in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Mavacamten Capsule 1
* Drug: Mavacamten Capsule 2
* Drug: Mavacamten Capsule 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index between 18 and 32 kilograms/meter squared (kg/m^2) inclusive, at the screening visit. Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1. Cytochrome P450 (CYP) 2C19 normal, rapid, or ultrarapid metabolizer, as determined by genotyping during screening. Exclusion Criteria: Any significant acute or chronic medical illness. Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, left ventricular systolic dysfunction, coronary heart disease; current, history, or family history of hypertrophic cardiomyopathy; or evidence of prior myocardial infarction based on ECGs. CYP2C19 poor (*2/*2, *3/*3, or *2/*3) or intermediate (*1/*2, *1/*3, *2/*17) metabolizer, as determined by genotyping during screening. Use of CYP2C19 and CYP3A4 inducers or inhibitors within 28 days of study intervention administration. 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: Sequence 1<br> | Drug: Mavacamten Capsule 1<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;Drug: Mavacamten Capsule 2<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;Drug: Mavacamten Capsule 3<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;|
| Experimental: Sequence 2<br> | Drug: Mavacamten Capsule 1<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;Drug: Mavacamten Capsule 2<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;Drug: Mavacamten Capsule 3<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;|
| Experimental: Sequence 3<br> | Drug: Mavacamten Capsule 1<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;Drug: Mavacamten Capsule 2<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;Drug: Mavacamten Capsule 3<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;|
| Experimental: Sequence 4<br> | Drug: Mavacamten Capsule 1<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;Drug: Mavacamten Capsule 2<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;Drug: Mavacamten Capsule 3<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;|
| Experimental: Sequence 5<br> | Drug: Mavacamten Capsule 1<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;Drug: Mavacamten Capsule 2<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;Drug: Mavacamten Capsule 3<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;|
| Experimental: Sequence 6<br> | Drug: Mavacamten Capsule 1<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;Drug: Mavacamten Capsule 2<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;Drug: Mavacamten Capsule 3<br>* Specified dose on specified days<br>* Other names: BMS-986427, MYK-461;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Serum Concentration-time Curve from Time 0 to 72 Hours [AUC(0-72)] |  | From Day 1 to Day 4 of each period | 
| Time of Maximum Observed Serum Concentration (Tmax) |  | From Day 1 up to Day 35±2 of each period | 
| Terminal Half-life (T-HALF) |  | From Day 1 up to Day 35±2 of each period | 
| Number of Participants with Adverse Events (AEs) |  | Up to 35 days post discontinuation of dosing | 
| Number of Participants with Serious Adverse Events (SAEs) |  | Up to 35 days post discontinuation of dosing | 
| Number of Participants with Vital Sign Abnormalities |  | Up to 35 days post discontinuation of dosing | 
| Number of Participants with Electrocardiograms (ECG) Abnormalities |  | Up to 35 days post discontinuation of dosing | 
| Number of Participants with Physical Examination Abnormalities |  | Up to 35 days post discontinuation of dosing | 
| Number of Participants with Clinical Laboratory Evaluation Abnormalities |  | Up to 35 days post discontinuation of dosing | 

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