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Completed

NCT Number: NCT05362045

A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants

The purpose of this study is to evaluate the effects on the single-dose drug levels of mavacamten in healthy participants.

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Key information

Conditions

Healthy Participants Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advanced Pharma CR, LLC, Miami, Florida, United States

Loading trial locations.

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, electrocardiograms (ECGs), and clinical laboratory assessments within the normal range at the screening visit and/or on Day -1

Exclusion criteria

  • Current or recent (within 3 months of study intervention administration) gastrointestinal disease
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

Mavacamten

Drug

Specified dose on specified days

Other names: BMS-986427, MYK-461

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to approximately 1 month

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

    Time frame: Up to approximately 1 month

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

    Time frame: Up to approximately 1 month

Secondary outcomes

  1. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to approximately 1 month

  2. Terminal half-life (T-HALF)

    Time frame: Up to approximately 1 month

  3. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 1 month

  4. Number of participants with serious adverse events (SAEs)

    Time frame: Up to approximately 1 month

  5. Number of participants with vital sign abnormalities exceeding predefined thresholds

    Time frame: Up to approximately 1 month

  6. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to approximately 1 month

  7. Number of participants with physical exam abnormalities

    Time frame: Up to approximately 1 month

  8. Number of participants with clinical laboratory evaluation abnormalities

    Time frame: Up to approximately 1 month

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Bioequivalence Study of a Single Dose of 15-mg Mavacamten Capsule Versus a Single Dose of 3 x 5-mg Mavacamten Capsules in Healthy Participants

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 5, 2022
Registry last updated
Nov 21, 2022

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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