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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05362045
Collaborator
(none)
156
Enrollment
4
Locations
2
Arms
2.2
Anticipated Duration (Months)
39
Patients Per Site
18
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
156 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
May 16, 2022
Anticipated Primary Completion Date :
Jul 21, 2022
Anticipated Study Completion Date :
Jul 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mavacamten- Dose A

Drug: Mavacamten
Specified dose on specified days
Other Names:
  • BMS-986427
  • MYK-461

    		•
    Experimental: Mavacamten- Dose B

    Drug: Mavacamten
    Specified dose on specified days
    Other Names:
  • BMS-986427
  • MYK-461

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [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)) [Up to approximately 1 month]

    3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF)) [Up to approximately 1 month]

    Secondary Outcome Measures

    1. Time of maximum observed plasma concentration (Tmax) [Up to approximately 1 month]

    2. Terminal half-life (T-HALF) [Up to approximately 1 month]

    3. Number of participants with adverse events (AEs) [Up to approximately 1 month]

    4. Number of participants with serious adverse events (SAEs) [Up to approximately 1 month]

    5. Number of participants with vital sign abnormalities exceeding predefined thresholds [Up to approximately 1 month]

    6. Number of participants with electrocardiogram (ECG) abnormalities [Up to approximately 1 month]

    7. Number of participants with physical exam abnormalities [Up to approximately 1 month]

    8. Number of participants with clinical laboratory evaluation abnormalities [Up to approximately 1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical pharmacology of Miami Miami Florida United States 33014
    2 Advanced Pharma CR, LLC Miami Florida United States 33147
    3 QPS Springfield Springfield Missouri United States 65802
    4 Ppd Phase I Clinic Austin Texas United States 78744

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05362045
    Other Study ID Numbers:
    • CV027-070
    First Posted:
    May 5, 2022
    Last Update Posted:
    Jun 16, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Mavacamten
    Healthy Participants
    Bioequivalence
    Hypertrophic Cardiomyopathy

    Study Results

    No Results Posted as of Jun 16, 2022