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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mavacamten | Experimental |
| |
| Mavacamten and activated charcoal with sorbitol - Dose A | Experimental |
| |
| Mavacamten and activated charcoal with sorbitol - Dose B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavacamten | Drug | Specified dose on specified days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Dallas | Texas | 75247-4989 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38926266 | Derived | Merali S, Chiang M, Sychterz C, Chao L, Simmons T, Xu Y, Zhao A, Attanasio M, Murthy B, Perera V. Effect of Activated Charcoal on Mavacamten Pharmacokinetics in Healthy Participants. Am J Cardiovasc Drugs. 2024 Jul;24(4):569-575. doi: 10.1007/s40256-024-00659-z. Epub 2024 Jun 26. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| D000881 | Anthrax |
| ID | Term |
|---|---|
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C000605992 | MYK-461 |
| D002606 | Charcoal |
| D013012 | Sorbitol |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D013402 | Sugar Alcohols |
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| Activated Charcoal with Sorbitol | Drug | Specified dose on specified days |
|
| 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 |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |
| D007239 | Infections |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |