A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose 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 of co-administration of activated charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.

Official Title
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An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Mavacamten
* Drug: Activated Charcoal with Sorbitol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index between 18 and 30 kg/m^2, inclusive, at the Screening Visit Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments Exclusion Criteria: Current or recent (within 3 months of study intervention administration) gastrointestinal disease History of sorbitol or fructose intolerance or inability to tolerate activated charcoal 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<br> | Drug: Mavacamten<br>* Specified dose on specified days<br>|
| Experimental: Mavacamten and activated charcoal with sorbitol - Dose A<br> | Drug: Mavacamten<br>* Specified dose on specified days<br>Drug: Activated Charcoal with Sorbitol<br>* Specified dose on specified days<br>|
| Experimental: Mavacamten and activated charcoal with sorbitol - Dose B<br> | Drug: Mavacamten<br>* Specified dose on specified days<br>Drug: Activated Charcoal with Sorbitol<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF)) |  | Up to 2 months | 
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T)) |  | Up to 2 months | 
| Maximum observed plasma concentration (Cmax) |  | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 3 months | 
| Number of participants with serious adverse events (SAEs) |  | Up to 3 months | 
| Number of participants with vital sign abnormalities exceeding predefined thresholds |  | Up to 3 months | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 3 Months | 
| Number of participants with physical exam abnormalities |  | Up to 3 months | 
| Number of participants with clinical laboratory evaluation abnormalities |  | Up to 3 months | 
| Time of maximum observed plasma concentration (Tmax) |  | Up to 1 month | 
| Apparent terminal plasma half-life (T-HALF) |  | Up to 2 months | 
| Concentration at 24 hours (C24) |  | Up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mavacamten, Sorbitol, Activated Charcoal