A Study to Evaluate the Effects of Mavacamten in Healthy Participants

NCT05719805 | Completed Phase 1 FDA Drug

• 1 other identifier: CV027-1090
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Participants

Keywords

Hypertrophic cardiomyopathy (HCM); Left ventricular (LV) hypertrophy; Bioequivalence; Left Ventricular Outflow Tract Obstruction; Heart diseases; Cardiovascular diseases

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  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

• 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 Outcomes (8)

• Time of maximum observed plasma concentration (Tmax)

  Predose and post-dose up to Day 80

• Terminal Half-life (T-Half)

  Predose and post-dose up to Day 80

• Number of Participants with Adverse Events (AEs)

  Up to Day 80

• Number of Participants with Serious AEs (SAEs)

  Up to Day 80

• Number of Participants with Vital Sign Abnormalities

  Up to Day 80

Study Arms (2)

Mavacamten Dose 1

EXPERIMENTAL

Drug: Mavacamten

Mavacamten Dose 2

EXPERIMENTAL

Drug: Mavacamten

Interventions

Mavacamten DRUG

Specified dose on specified days

Also known as: MYK-461

Mavacamten Dose 1; Mavacamten Dose 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0001

Miami, Florida, 33136, United States

Location

Local Institution - 0002

Saint Paul, Minnesota, 55114, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Hypertrophy; Ventricular Outflow Obstruction, Left; Heart Diseases; Cardiovascular Diseases

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Cardiomyopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ventricular Outflow Obstruction

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: February 20, 2023
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)