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NCT Number: NCT07226817

A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 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 drug levels of selected BMS-986435 tablet formulations will also be evaluated.

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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

Quotient Miami

Miami, Florida, 33126, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

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

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 28

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

    Time frame: Up to Day 28

  3. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to Day 28

Secondary outcomes

  1. Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h))

    Time frame: Up to Day 28

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 28

  3. Half-life (T-HALF)

    Time frame: Up to Day 28

  4. Apparent total body clearance (CLT/F)

    Time frame: Up to Day 28

  5. Volume of distribution of terminal phase (Vz/F)

    Time frame: Up to Day 28

  6. Number of participants with Adverse Events (AEs)

    Time frame: Up to Day 35

  7. Number of participants with Serious AEs (SAEs)

    Time frame: Up to Day 35

  8. Number of participants with clinical laboratory abnormalities

    Time frame: Up to Day 28

  9. Number of participants with vital sign abnormalities

    Time frame: Up to Day 28

  10. Number of participants with physical examination abnormalities

    Time frame: Up to Day 28

  11. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 28

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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 Formulations (Part 3) in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2025
Registry last updated
Aug 12, 2026

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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