Single-dose Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- Maximum observed plasma concentration (Cmax) of BMS-986141
研究概览
简要总结
An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women not of childbearing potential (WNOCBP), and males, ages 18 to 70 years, inclusive.
- •BMI of 20.0 to 38.0 kg/m2 inclusive
- •Participants who a history of normal renal function
- •Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
- •Healthy subjects to the extent possible matched to four subjects with hepatic impairment with regard to body weight, age and gender, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
排除标准
- •Any nonhepatic significant acute or chronic medical illness that could affect participant safety or data interpretation as determined by the investigator.
- •History of recurrent dizziness or fall risk within 4 weeks of study drug administration
- •History of primarily cholestatic liver diseases, autoimmune liver disease, metastatic liver disease or active alcoholic hepatitis
- •History of known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Mild Hepatic Impairment Subjects
Subjects given an oral dose of BMS-986141.
干预措施: BMS-986141 (Drug)
Moderate Hepatic Impairment Subjects
Subjects given an oral dose of BMS-986141.
干预措施: BMS-986141 (Drug)
Healthy Subjects
Subjects given an oral dose of BMS-986141.
干预措施: BMS-986141 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of BMS-986141
时间窗: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141
时间窗: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141
时间窗: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141
时间窗: Days 1-7 (healthy) Days 1-10 (heaptic Impairment)
次要结局
- Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation.(Days 1-7 (healthy) Days 1-10 (heaptic Impairment))