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A Study to Assess the Drug Interaction Between MYK-224 and Itraconazole and Verapamil in Healthy Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05304533
Collaborator
(none)
42
Enrollment
1
Location
3
Arms
5.9
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of co-administration of itraconazole or verapamil on the drug levels of MYK-224 in healthy participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, 3-Arm, Parallel Design Pharmacokinetic Interaction Study Between MYK-224 and Cytochrome P450 3A4 Inhibitors Itraconazole and Verapamil in Healthy Participants
Actual Study Start Date :
Apr 21, 2022
Anticipated Primary Completion Date :
Oct 19, 2022
Anticipated Study Completion Date :
Oct 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: MYK-224

Drug: MYK-224
Specified dose on specified days
Other Names:
  • BMS-986435

    		•
    Experimental: Arm 2: MYK-224 + Itraconazole

    Drug: MYK-224
    Specified dose on specified days
    Other Names:
  • BMS-986435

    • Drug: Itraconazole
    Specified dose on specified days
    Experimental: Arm 3: MYK-224 + Verapamil

    Drug: MYK-224
    Specified dose on specified days
    Other Names:
  • BMS-986435

    • Drug: Verapamil
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Up to 36 days]

    2. Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) [Up to 36 days]

    3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) [Up to 36 days]

    Secondary Outcome Measures

    1. Time of maximum observed plasma concentration (Tmax) [Up to 36 days]

    2. Apparent terminal plasma half-life (T-HALF) [Up to 36 days]

    3. Apparent total body clearance (CLT/F) [Up to 36 days]

    4. Number of participants with adverse events (AEs) [Up to 52 days]

    5. Number of participants with serious adverse events (SAEs) [Up to 52 days]

    6. Number of participants with adverse events leading to discontinuation [Up to 52 days]

    7. Number of participants with vital sign abnormalities [Up to 52 days]

    8. Number of participants with electrocardiogram (ECG) abnormalities [Up to 52 days]

    9. Measurement of left ventricular ejection fraction (LVEF) [Up to 52 days]

    10. Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI) [Up to 52 days]

    11. Measurement of left ventricular fractional shortening (LVFS) [Up to 52 days]

    12. Measurement of left ventricular global longitudinal strain (LV GLS) [Up to 52 days]

    13. Measurement of left ventricle stroke volume (LVSV) [Up to 52 days]

    14. Number of participants with physical exam abnormalities [Up to 52 days]

    15. Number of participants with clinical laboratory abnormalities [Up to 52 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Body mass index between 18 and 30 kg/m^2, inclusive

    • Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine laboratory assessments

    • Adequate acoustic windows to enable accurate transthoracic echocardiographic assessment

    • Left Ventricular Ejection Fraction (LVEF) ≥60% at screening and ≥55% prior to MYK-224 dosing

    Exclusion Criteria:

    • Any acute or chronic medical illness

    • History of dizziness and/or recurrent headaches

    • History of heart disease

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Labcorp CRU Dallas Texas United States 75247

    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:
    NCT05304533
    Other Study ID Numbers:
    • CV029-005
    First Posted:
    Mar 31, 2022
    Last Update Posted:
    Jun 10, 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
    MYK-224
    Itraconazole
    Verapamil
    Additional relevant MeSH terms:
    Itraconazole
    Verapamil

    Study Results

    No Results Posted as of Jun 10, 2022