A Study to Evaluate the Effects of Mavacamten in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Mavacamten

• Registration Number: NCT05719805
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-09
• Study Start: 2023-02-20
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mavacamten Dose 2	Mavacamten	-
Mavacamten Dose 1	Mavacamten	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])	Predose and post-dose up to Day 80
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])	Predose and post-dose up to Day 80
Maximum observed plasma concentration (Cmax)	Predose and post-dose up to Day 80

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Serious AEs (SAEs)	Up to Day 80
Number of Participants with Vital Sign Abnormalities	Up to Day 80
Number of Participants with Adverse Events (AEs)	Up to Day 80
Time of maximum observed plasma concentration (Tmax)	Predose and post-dose up to Day 80
Number of Participants with Physical Examination Abnormalities	Up to Day 80
Number of Participants with Electrocardiogram (ECG) Abnormalities	Up to Day 80
Terminal Half-life (T-Half)	Predose and post-dose up to Day 80
Number of Participants with Clinical Laboratory Abnormalities	Up to Day 80

Trial Locations

Locations (2)

Local Institution - 0002; 🇺🇸 Saint Paul, Minnesota, United States

Local Institution - 0001; 🇺🇸 Miami, Florida, United States