Hypertrophic Cardiomyopathy Clinical Trial

A Study to Evaluate the Effects of Mavacamten in Healthy Participants

Summary

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

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 1

Estimated Enrollment:

84

Study ID:

NCT05719805

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 2 Locations for this study

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Local Institution - 0001
Miami Florida, 33136, United States
Local Institution - 0002
Saint Paul Minnesota, 55114, United States

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 1

Estimated Enrollment:

84

Study ID:

NCT05719805

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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