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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05658146
Collaborator
(none)
96
Enrollment
3
Locations
6
Arms
6.6
Anticipated Duration (Months)
32
Patients Per Site
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Mavacamten Capsule 1
  • Drug: Mavacamten Capsule 2
  • Drug: Mavacamten Capsule 3
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Randomized, Single-dose, Three-way Crossover Study to Establish Bioequivalence of 5 mg Mavacamten Capsule 1 and 5 × 1 mg Mavacamten Capsule 2 to 5 mg Mavacamten Capsule 2 in Healthy Participants
Anticipated Study Start Date :
Jan 5, 2023
Anticipated Primary Completion Date :
Jul 24, 2023
Anticipated Study Completion Date :
Jul 24, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sequence 1

Drug: Mavacamten Capsule 1
Specified dose on specified days
Other Names:
  • BMS-986427, MYK-461

    • Drug: Mavacamten Capsule 2
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    • Drug: Mavacamten Capsule 3
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    		•
    Experimental: Sequence 2

    Drug: Mavacamten Capsule 1
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    • Drug: Mavacamten Capsule 2
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    • Drug: Mavacamten Capsule 3
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    		•
    Experimental: Sequence 3

    Drug: Mavacamten Capsule 1
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    • Drug: Mavacamten Capsule 2
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    • Drug: Mavacamten Capsule 3
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    		•
    Experimental: Sequence 4

    Drug: Mavacamten Capsule 1
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    • Drug: Mavacamten Capsule 2
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    • Drug: Mavacamten Capsule 3
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    		•
    Experimental: Sequence 5

    Drug: Mavacamten Capsule 1
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    • Drug: Mavacamten Capsule 2
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    • Drug: Mavacamten Capsule 3
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    		•
    Experimental: Sequence 6

    Drug: Mavacamten Capsule 1
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    • Drug: Mavacamten Capsule 2
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    • Drug: Mavacamten Capsule 3
    Specified dose on specified days
    Other Names:
  • BMS-986427, MYK-461

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Serum Concentration (Cmax) [From Day 1 up to Day 35±2 of each period]

    2. Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] [From Day 1 up to Day 35±2 of each period]

    3. Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)] [From Day 1 up to Day 35±2 of each period]

    Secondary Outcome Measures

    1. Area Under the Serum Concentration-time Curve from Time 0 to 72 Hours [AUC(0-72)] [From Day 1 to Day 4 of each period]

    2. Time of Maximum Observed Serum Concentration (Tmax) [From Day 1 up to Day 35±2 of each period]

    3. Terminal Half-life (T-HALF) [From Day 1 up to Day 35±2 of each period]

    4. Number of Participants with Adverse Events (AEs) [Up to 35 days post discontinuation of dosing]

    5. Number of Participants with Serious Adverse Events (SAEs) [Up to 35 days post discontinuation of dosing]

    6. Number of Participants with Vital Sign Abnormalities [Up to 35 days post discontinuation of dosing]

    7. Number of Participants with Electrocardiograms (ECG) Abnormalities [Up to 35 days post discontinuation of dosing]

    8. Number of Participants with Physical Examination Abnormalities [Up to 35 days post discontinuation of dosing]

    9. Number of Participants with Clinical Laboratory Evaluation Abnormalities [Up to 35 days post discontinuation of dosing]

    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 kilograms/meter squared (kg/m^2) inclusive, at the screening visit.

    • Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1.

    • Cytochrome P450 (CYP) 2C19 normal, rapid, or ultrarapid metabolizer, as determined by genotyping during screening.

    Exclusion Criteria:

    • Any significant acute or chronic medical illness.

    • Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, left ventricular systolic dysfunction, coronary heart disease; current, history, or family history of hypertrophic cardiomyopathy; or evidence of prior myocardial infarction based on ECGs.

    • CYP2C19 poor (*2/*2, *3/*3, or *2/*3) or intermediate (*1/*2, *1/*3, *2/*17) metabolizer, as determined by genotyping during screening.

    • Use of CYP2C19 and CYP3A4 inducers or inhibitors within 28 days of study intervention administration.

    Note: Other protocol-defined inclusion/exclusion criteria apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anaheim Clinical Trials Llc Anaheim California United States 92801
    2 Quotient Sciences Miami Florida United States 33126
    3 QPS Springfield Springfield Missouri United States 65802

    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:
    NCT05658146
    Other Study ID Numbers:
    • CV027-1052
    First Posted:
    Dec 20, 2022
    Last Update Posted:
    Dec 20, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Healthy Participants
    Mavacamten
    Bioequivalence
    Additional relevant MeSH terms:
    Sulconazole

    Study Results

    No Results Posted as of Dec 20, 2022