Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Maximum observed plasma concentration (Cmax) of BMS-986177
研究概览
简要总结
A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment, moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and tolerability in these subjects
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. Women must have documented proof they are not of childbearing potential
- •BMI of 20.0 to 38.0 kg/m2, inclusive
- •Hepatic subjects classified as Child-Pugh mild (Class A) or Child-Pugh moderate (Class B) who have had no significant change to disease status in past 6 months and are on stable treatment regimen
- •Healthy subjects must not have clinically significant deviations from normal in medical history, physical exam, ECGs, vital signs or clinical lab values
排除标准
- •Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation
- •Use of corticosteroids, nonsteroidal anti-inflammatory compounds, aspirin or other antiplatelet agents or anticoagulants within 2 weeks of dosing
- •Healthy subjects must not have used tobacco or have a history of drug or alcohol abuse within the last 6 months
- •Subjects must not have a current or recent (within 3 months) GI disease that increases participant risk of GI bleeding or interferes with absorption of the study drug
- •Other protocol defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Mild Hepatic Subjects
Subjects are given a single dose of BMS-986177
干预措施: BMS-986177 (Drug)
Moderate Hepatic Subjects
Subjects are given a single dose of BMS-986177
干预措施: BMS-986177 (Drug)
Healthy Match Subjects
Subjects are given a single dose of BMS-986177
干预措施: BMS-986177 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of BMS-986177
时间窗: Up to 5 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-987177
时间窗: Up to 5 days
Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177
时间窗: Up to 5 days
Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177
时间窗: Up to 5 days
次要结局
- Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation(Screening until 30 days after discontinuation of dosing or subject's participation)
- Number of participants with clinical laboratory abnormalities(Screening until 30 days after discontinuation of dosing or subject's participation)
- Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG)(Screening until 30 days after discontinuation of dosing or subject's participation)
- Number of participants with vital sign abnormalities(Screening until 30 days after discontinuation of dosing or subject's participation)