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Completed

NCT Number: NCT05405543

A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese Participants

The purpose of this study is to evaluate the effects of both single and multiple dose drug levels of MYK-224 in healthy adult Japanese participants.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy as determined by medical history, physical examination, vital signs,12-lead electrocardiogram and routine laboratory assessments
  • Must have documented left Ventricular Ejection Fraction (LVEF) ≥60% (2D biplane Simpson's Method) at screening as determined by the echocardiographic core laboratory.

Exclusion criteria

  • Any acute or chronic medical illness
  • History of heart disease

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

MYK-224

Drug

Specified dose on specified days

Other names: BMS-986435

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 72 days

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to 72 days

  3. 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 72 days

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 130 days

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

    Time frame: Up to 130 days

  3. Number of participants with adverse events leading to discontinuation

    Time frame: Up to 130 days

  4. Number of participants with vital sign abnormalities

    Time frame: Up to 72 days

  5. Number of participants with physical exam abnormalities

    Time frame: Up to 72 days

  6. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 72 days

  7. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 72 days

  8. Measurement of left ventricular ejection fraction (LVEF)

    Time frame: Up to 72 days

  9. Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)

    Time frame: Up to 72 days

  10. Measurement of left ventricular fractional shortening (LVFS)

    Time frame: Up to 72 days

  11. Measurement of left ventricular global longitudinal strain (LV GLS)

    Time frame: Up to 72 days

  12. Measurement of left ventricle stroke volume (LVSV)

    Time frame: Up to 72 days

  13. Measurement of lateral and septal early diastolic mitral annular velocity (e')

    Time frame: Up to 72 days

  14. Measurement of early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e')

    Time frame: Up to 72 days

  15. Measurement of early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio)

    Time frame: Up to 72 days

  16. Measurement of left ventricular (LV) mass index

    Time frame: Up to 72 days

  17. Measurement of left atrial volume index

    Time frame: Up to 72 days

  18. Measurement of interventricular septal thickness

    Time frame: Up to 72 days

  19. Measurement of posterior wall thickness

    Time frame: Up to 72 days

  20. Measurement of LV end diastolic volume

    Time frame: Up to 72 days

  21. Measurement of LV end diastolic volume index

    Time frame: Up to 72 days

  22. Measurement of LV end systolic volume

    Time frame: Up to 72 days

  23. Measurement of LV end systolic volume index

    Time frame: Up to 72 days

  24. Relative bioavailability of test formulation compared to the reference formulation based on Cmax

    Time frame: Up to 72 days

  25. Relative bioavailability of test formulation compared to the reference formulation based on AUC(0-T)

    Time frame: Up to 72 days

  26. Relative bioavailability of test forumulation compared to the reference formulation based on area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)

    Time frame: Up to 72 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1 Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of MYK-224 in Healthy Adult Japanese Participants

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 6, 2022
Registry last updated
Jan 13, 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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