Recruiting
Phase 1

BMS-986435

Sponsor:

Bristol-Myers Squibb

Code:

NCT07248839

Conditions

Healthy Volunteers

Hepatic Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

BMS-986435

Study Details

Brief summary:

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

Conditions

Healthy Volunteers

Hepatic Impairment

Study ID

NCT07248839

Start date

Dec 15, 2025

Status verified date

Jun, 2026

Completion date

Aug 5, 2026

Anticipated

Primary completion date

Aug 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

Mild Hepatic Impairment

experimental: Arm B

Moderate Hepatic Impairment

experimental: Arm C

Matched participants with normal hepatic function

Interventions

BMS-986435

Specified dose on specified days

Primary outcome measure

  • Maximum observed concentration (Cmax) [ Time Frame: Up to Day 45 ]
  • Area under the concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T) [ Time Frame: Up to Day 45 ]
  • Area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF) [ Time Frame: Up to Day 45 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Arizona Clinical Trials

Recruiting

Chandler, Arizona, United States, 85225

Contacts

Anita Kohli, Site 0003

434-825-0921

Panax Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Robert Perry, Site 0002

305-698-4500

Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

Contacts

Eric Lawitz, Site 0001

210-253-3426

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-06-12.