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Completed

NCT Number: NCT06476821

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics following a single oral dose of BMS-986435 in healthy adult Chinese 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

Xuhui District, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body weight of ≥ 50 kg and body mass index between 18.0 and 28.0 kg/m2, inclusive, at screening.
  • Participants must be Chinese (both biological parents are ethnically Chinese).
  • Participant has documented LVEF ≥ 60% (2D biplane Simpson's Method) at screening as determined by the echocardiographic core laboratory.

Exclusion criteria

  • Any acute or chronic medical illness.
  • Head injury in the last 2 years, intracranial tumor, or aneurysm.
  • History of malignancy of any type, except in situ cervical cancer > 5 years prior to the screening visit or surgically excised nonmelanomatous skin cancers > 2 years prior to the screening visit.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BMS-986435

Drug

Specified dose on specified days

Other names: MYK-224

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to Day 30

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 30

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

    Time frame: Up to Day 30

Secondary outcomes

  1. Number of participants with Adverse Events

    Time frame: From date of written consent up to 28 days post last dose

  2. Number of participants with Serious Adverse Events

    Time frame: From date of written consent up to 28 days post last dose

  3. Number of participants with AEs leading to discontinuation

    Time frame: From date of written consent up to 28 days post last dose

  4. Number of participants with vital sign abnormalities

    Time frame: Up to Day 31

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 31

  6. Number of participants with echocardiogram abnormalities

    Time frame: Up to Day 30

  7. Number of participants with physical examination abnormalities

    Time frame: Up to Day 31

  8. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 31

  9. Echocardiographic measures of cardiac systolic function: left ventricular ejection fraction (LVEF)

    Time frame: Up to Day 30

  10. Echocardiographic measures of cardiac systolic function: left ventricular outflow tract velocity time integral (LVOT-VTI)

    Time frame: Up to Day 30

  11. Echocardiographic measures of cardiac systolic function: left ventricular fractional shortening (LVFS)

    Time frame: Up to Day 30

  12. Echocardiographic measures of cardiac systolic function: left ventricular global longitudinal strain (LV GLS)

    Time frame: Up to Day 30

  13. Echocardiographic measures of cardiac systolic function: left ventricle stroke volume (LVSV)

    Time frame: Up to Day 30

  14. Echocardiographic measures of cardiac diastolic function: lateral early diastolic mitral annular velocity (e')

    Time frame: Up to Day 30

  15. Echocardiographic measures of cardiac diastolic function: septal e'

    Time frame: Up to Day 30

  16. Echocardiographic measures of cardiac diastolic function: early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e')

    Time frame: Up to Day 30

  17. Echocardiographic measures of cardiac diastolic function: early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio)

    Time frame: Up to Day 30

  18. Echocardiographic measures of cardiac structure: LV mass index

    Time frame: Up to Day 30

  19. Echocardiographic measures of cardiac structure: LV atrial volume index

    Time frame: Up to Day 30

  20. Echocardiographic measures of cardiac structure: interventricular septal thickness

    Time frame: Up to Day 30

  21. Echocardiographic measures of cardiac structure: posterior wall thickness

    Time frame: Up to Day 30

  22. Echocardiographic measures of cardiac structure: LV end diastolic volume

    Time frame: Up to Day 30

  23. Echocardiographic measures of cardiac structure: LV end systolic volume

    Time frame: Up to Day 30

  24. Echocardiographic measures of cardiac structure: LV end systolic volume index

    Time frame: Up to Day 30

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2024
Registry last updated
Nov 19, 2024

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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