A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants

March 3, 2026 updated by: Bristol-Myers Squibb

A Phase 1, Open-label, Single-site, Multi-part, Non-randomized, Parallel-group Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations (Parts 1 & 2) and Food Effect on the Selected BMS-986435 Tablet Formulation (Part 3) in Healthy Adult Participants

This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the selected BMS-986435 tablet formulation will also be evaluated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33126
        • Recruiting
        • Quotient Miami
        • Contact:
          • Juliet Vento

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Participants must have a body weight of ≥ 45 kg and BMI between 18 and 32 kg/m2, inclusive
  • Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory assessments
  • Participants must have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality at screening, as determined by local transthoracic echocardiogram (TTE) assessment
  • Other protocol-defined Inclusion/Exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment B
Drug: BMS-986435
Specified dose on specified days
Other Names:
  • MYK-224
Experimental: Treatment C
Drug: BMS-986435
Specified dose on specified days
Other Names:
  • MYK-224
Experimental: Treatment A
Drug: BMS-986435
Specified dose on specified days
Other Names:
  • MYK-224
Experimental: Treatment D
Drug: BMS-986435
Specified dose on specified days
Other Names:
  • MYK-224
Experimental: Treatment E
Drug: BMS-986435
Specified dose on specified days
Other Names:
  • MYK-224
Experimental: Treatment F
Drug: BMS-986435
Specified dose on specified days
Other Names:
  • MYK-224
Experimental: Treatment G
Drug: BMS-986435
Specified dose on specified days
Other Names:
  • MYK-224

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration (Cmax)
Time Frame: Up to Day 28
Up to Day 28
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time Frame: Up to Day 28
Up to Day 28
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time Frame: Up to Day 28
Up to Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Time of maximum observed concentration (Tmax)
Time Frame: Up to Day 28
Up to Day 28
Half-life (T-HALF)
Time Frame: Up to Day 28
Up to Day 28
Apparent total body clearance (CLT/F)
Time Frame: Up to Day 28
Up to Day 28
Volume of distribution of terminal phase (Vz/F)
Time Frame: Up to Day 28
Up to Day 28
Number of participants with Adverse Events (AEs)
Time Frame: Up to Day 35
Up to Day 35
Number of participants with Serious AEs (SAEs)
Time Frame: Up to Day 35
Up to Day 35
Number of participants with clinical laboratory abnormalities
Time Frame: Up to Day 28
Up to Day 28
Number of participants with vital sign abnormalities
Time Frame: Up to Day 28
Up to Day 28
Number of participants with physical examination abnormalities
Time Frame: Up to Day 28
Up to Day 28
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to Day 28
Up to Day 28
Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h))
Time Frame: Up to Day 28
Up to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 7, 2025

First Submitted That Met QC Criteria

November 7, 2025

First Posted (Actual)

November 10, 2025

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CV029-1024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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