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The purpose of this study to assess the relative bioavailability of 5 mg Mavacamten opened capsule administered via nasogastric tube compared to intact oral 5 mg Mavacamten in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence ABC | Experimental |
| |
| Sequence BCA | Experimental |
| |
| Sequence CAB | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A: Mavacamten intact oral capsule | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to 37 days | |
| Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC[0-T]) | Up to 37 days | |
| Area under the concentration-time curve from time 0 to 72 hours (AUC[0-72]) | Up to 37 days | |
| Area under the concentration-time curve from time 0 to infinite time (AUC[0-INF]) | Up to 37 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed plasma concentration (Tmax) | Up to 37 days | |
| Terminal half-life (T-HALF) | Up to 37 days | |
| Apparent clearance (CLT/F) |
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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 | San Antonio | Texas | 78217 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-andresearch/disclosure-commitment.html
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| Treatment B: Mavacamten open capsule in suspension | Drug | Specified dose on specified days |
|
| Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) | Drug | Specified dose on specified days |
|
| Up to 37 days |
| Apparent volume of distribution (Vz/F) | Up to 37 days |
| Number of participants with adverse events (AEs) | Up to 37 days |
| Number of participants with serious adverse events (SAEs) | Up to 37 days |
| Number of participants with vital sign abnormalities | Up to 37 days |
| Number of participants with electrocardiogram (ECG) findings | Up to 37 days |
| Number of participants with physical examination findings | Up to 37 days |
| Number of participants with abnormalities in clinical laboratory evaluations | Up to 37 days |