A Study to Evaluate the Effects of Mavacamten in Healthy Participants

• Status: Not yet recruiting
• Trial end date: 2023-07-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb

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.