A Study to Evaluate the Effects of Mavacamten in Healthy Participants

Healthy Participants Clinical Trial

Official title:

An Open-label, Randomized, Single-dose, 2-way Crossover Study to Establish Bioequivalence of 1 × 15-mg Mavacamten Capsule to 3 × 5-mg Mavacamten Capsules in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05719805
• Other study ID #: CV027-1090
• Status: Completed
• Phase: Phase 1
• Start date: February 20, 2023
• Est. completion date: July 25, 2023

Study information

• Verified date: October 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Mavacamten
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Miami	Florida
United States	Local Institution - 0002	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Predose and post-dose up to Day 80
Primary	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
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])		Predose and post-dose up to Day 80
Secondary	Time of maximum observed plasma concentration (Tmax)		Predose and post-dose up to Day 80
Secondary	Terminal Half-life (T-Half)		Predose and post-dose up to Day 80
Secondary	Number of Participants with Adverse Events (AEs)		Up to Day 80
Secondary	Number of Participants with Serious AEs (SAEs)		Up to Day 80
Secondary	Number of Participants with Vital Sign Abnormalities		Up to Day 80
Secondary	Number of Participants with Electrocardiogram (ECG) Abnormalities		Up to Day 80
Secondary	Number of Participants with Physical Examination Abnormalities		Up to Day 80
Secondary	Number of Participants with Clinical Laboratory Abnormalities		Up to Day 80

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting