NCT07248839招募中1 期
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
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年12月15日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Arm A
Experimental
Mild Hepatic Impairment
干预措施: BMS-986435 (Drug)
Arm B
Experimental
Moderate Hepatic Impairment
干预措施: BMS-986435 (Drug)
Arm C
Experimental
Matched participants with normal hepatic function
干预措施: BMS-986435 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Up to Day 45
Area under the concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
时间窗: Up to Day 45
Area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)
时间窗: Up to Day 45
次要结局
- Number of participants with adverse events (AEs)(Up to Day 45)
- Number of participants with serious adverse events (SAEs)(Up to Day 45)
- Time of maximum observed concentration (Tmax)(Up to Day 45)
- Half-life (T-HALF)(Up to Day 45)
- Apparent total body clearance (CLT/F)(Up to Day 45)
- Apparent volume of distribution at terminal phase (Vz/F)(Up to Day 45)
研究者
研究点 (3)
Loading locations...
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