Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BMS-986435.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers, Hepatic Impairment. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
Interventions
- Drug BMS-986435
Specified dose on specified days
Primary outcome measures
- 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]
Secondary outcome measures (6)
- Number of participants with adverse events (AEs) [Time frame: Up to Day 45]
- Number of participants with serious adverse events (SAEs) [Time frame: Up to Day 45]
- Time of maximum observed concentration (Tmax) [Time frame: Up to Day 45]
- Half-life (T-HALF) [Time frame: Up to Day 45]
- Apparent total body clearance (CLT/F) [Time frame: Up to Day 45]
- Apparent volume of distribution at terminal phase (Vz/F) [Time frame: Up to Day 45]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Arizona Clinical Trials — Chandler
- Panax Clinical Research — Miami Lakes
- Texas Liver Institute — San Antonio
Identifiers
NCT: NCT07248839 · CV029-1017