A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Fu… (NCT07248839) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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
24 participantsStarted 2025-12-15
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
Maximum observed concentration (Cmax)
Timeframe: Up to Day 45
2
Area under the concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
Timeframe: Up to Day 45
3
Area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)
Timeframe: Up to Day 45
Trial details
NCT IDNCT07248839
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2026-04-06
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com