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NCT Number: NCT07248839

A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Different Degrees of Hepatic Impairment

The purpose of this study is to determine the pharmacokinetic and safety of BMS-986435 in participants with normal hepatic function and participants with different degrees of hepatic impairment

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arizona Clinical Trials, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant must have documented LVEF ≥ 60% (2D biplane Simpson's Method) and absence of cardiac abnormality.
  • Participant must have body weight of > 50 kg and BMI of 18.0 kg/m2 through 40 kg/m2, inclusive, at screening.
  • Participants must have adequate renal function at screening as evidenced by an eGFR > 60 mL/min/1.73 m2 for participants calculated with the CKD-EPI Creatinine Equation (2021).

Exclusion criteria

  • Participants must not have history of or current uncontrolled or unstable clinically significant disorder, condition, or disease that, in the opinion of the investigator and CRO MM, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
  • Participants must not have head injury in the last 2 years, intracranial tumor, or aneurysm.
  • Participants must not have history of malignancy of any type, except in situ cervical cancer >5 years prior to the screening visit or surgically excised non-melanomatous skin cancer >2 years prior to the screening visit.
  • Participants must not have History of heart disease (including coronary artery disease, heart failure/LV systolic dysfunction, cardiomyopathy, or clinically significant structural disease).
  • Other protocol defined inclusion/exclusion criteria applies.

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 45

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

    Time frame: Up to Day 45

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

    Time frame: Up to Day 45

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to Day 45

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

    Time frame: Up to Day 45

  3. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 45

  4. Half-life (T-HALF)

    Time frame: Up to Day 45

  5. Apparent total body clearance (CLT/F)

    Time frame: Up to Day 45

  6. Apparent volume of distribution at terminal phase (Vz/F)

    Time frame: Up to Day 45

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Mild and Moderate Hepatic Impairment

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Jun 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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