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
| NCT ID | NCT07248839 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-08-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-12-15 with a primary completion date of 2026-08-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT07248839 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07248839 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07248839 currently recruiting?
Yes, NCT07248839 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT07248839 trial being conducted?
This trial is being conducted at Chandler, United States, Miami Lakes, United States, San Antonio, United States.
Who is sponsoring the NCT07248839 clinical trial?
NCT07248839 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 24 participants.