An Open-label, Two-Part, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986263 in Participants With Varying Degrees of Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of components of BMS-986263 for injection
研究概览
简要总结
The primary purpose of this study is to evaluate the effect of liver impairment on the safety and pharmacokinetics (PK) of BMS-986263
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •BMI ≥ 18 kg/m^2 and weight ≥ 50 kg at screening (BMI = weight [kg]/height [m^2]).
- •Participants with normal hepatic function as judged by the investigator
- •Participants with hepatic impairment as judged by the investigator
排除标准
- •Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant.
- •Any major surgery within 4 weeks of study drug administration
- •Previous exposure to BMS-986263
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Group A: Mild Hepatic Impairment
Part 1
干预措施: BMS-986263 (Drug)
Group B: Moderate Hepatic Impairment
Part 1
干预措施: BMS-986263 (Drug)
Group C: Severe Hepatic Impairment
Part 2
干预措施: BMS-986263 (Drug)
Group D: Normal Hepatic function (control group)
Part 1
干预措施: BMS-986263 (Drug)
Group E: Normal Hepatic Function (optional, control group)
Part 2
干预措施: BMS-986263 (Drug)
结局指标
主要结局
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of components of BMS-986263 for injection
时间窗: Day 1 to Day 31
Terminal elimination half-life (T-Half) of components of BMS-986263 for injection
时间窗: Day 1 to Day 31
Maximum observed serum concentration (Cmax) of components of BMS-986263 for injection
时间窗: Day 1 to Day 31
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of components of BMS-986263 for injection
时间窗: Day 1 to Day 31
Total body clearance (CL) of components of BMS-986263 for injection
时间窗: Day 1 to Day 31
Volume of distribution (Vz) of components of BMS-986263 for injection
时间窗: Day 1 to Day 31
次要结局
- Incidence of Adverse Events (AEs)(Up to 31 days)
- Number of participants with abnormalities in clinical laboratory assessments(Up to 59 days)
- Number of participants with vital sign abnormalities(Up to 59 days)
- Incidence of AEs leading to discontinuation(Nonserious AEs: Up to 31 days ; SAEs: Up to 59 days or up to 30 days after dosing (whichever is longer).)
- Incidence of Serious Adverse Events (SAEs)(Up to 59 days or up to 30 days after dosing (whichever is longer))
- Number of participants with 12-lead electrocardiogram (ECG) abnormalities(Up to 59 days)
- Number of participants with physical examination abnormalities(Up to 59 days)