About this trial
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
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
BMS-986435
DrugSpecified dose on specified days
Treatment groups
Trial outcomes
Primary outcomes
Maximum observed concentration (Cmax)
Area under the concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
Area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)
Secondary outcomes
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Time of maximum observed concentration (Tmax)
Half-life (T-HALF)
Sponsors and contacts
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