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Completed

NCT Number: NCT05719805

A Study to Evaluate the Effects of Mavacamten in Healthy Participants

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mavacamten

Drug

Specified dose on specified days

Other names: MYK-461

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Predose and post-dose up to Day 80

  2. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])

    Time frame: Predose and post-dose up to Day 80

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])

    Time frame: Predose and post-dose up to Day 80

Secondary outcomes

  1. Time of maximum observed plasma concentration (Tmax)

    Time frame: Predose and post-dose up to Day 80

  2. Terminal Half-life (T-Half)

    Time frame: Predose and post-dose up to Day 80

  3. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 80

  4. Number of Participants with Serious AEs (SAEs)

    Time frame: Up to Day 80

  5. Number of Participants with Vital Sign Abnormalities

    Time frame: Up to Day 80

  6. Number of Participants with Electrocardiogram (ECG) Abnormalities

    Time frame: Up to Day 80

  7. Number of Participants with Physical Examination Abnormalities

    Time frame: Up to Day 80

  8. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Up to Day 80

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 9, 2023
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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