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CompletedNCT06476821Updated Nov 19, 2024

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

A Phase 1 interventional study of BMS-986435 in Healthy Volunteers, sponsored by Bristol-Myers Squibb. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2024, 1 year 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: BMS-986435

  • Experimental
    Arm 2

    Drug: BMS-986435

Interventions

  • DrugBMS-986435

    Specified dose on specified days

    Also known as: MYK-224

06

What researchers measure

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

07

Study locations

1 site
  • Local Institution - 0001
    Xuhui District, Shanghai 200032, China
08

References and documents

Individual participant data

Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06476821
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jun 26, 2024
Start date
Jun 27, 2024
Primary completion
Oct 11, 2024
Completion
Oct 11, 2024
Last update
Nov 19, 2024

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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