NCT04634149已完成1 期
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Normal Hepatic Function and Participants With Moderate and Severe Hepatic Impairment
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年11月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants or participants with hepatic impairment, as determined by medical history, physical exam, electrocardiogram (ECG), and clinical laboratory determinations
- •Body mass index (BMI) of 18.0 kg/m^2 to 40.0 kg/m^2, inclusive. BMI = weight (kg)/height (m^2)
排除标准
- •Any history of known or suspected congenital or acquired immunodeficiency state or condition that would have compromised the participant's immune status
- •History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Group A: Moderate Hepatic Impairment
Experimental
干预措施: BMS-986036 (Drug)
Group B: Severe Hepatic Impairment
Experimental
干预措施: BMS-986036 (Drug)
Group C: Normal Hepatic Function
Experimental
干预措施: BMS-986036 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 29 days
Time of maximum observed plasma concentration (Tmax)
时间窗: Up to 29 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T))
时间窗: Up to 29 days
次要结局
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 31 days)
- Number of participants with vital sign abnormalities(Up to 31 days)
- Number of participants with adverse events (AEs)(Up to 31 days)
- Number of participants with clinical laboratory abnormalities(Up to 31 days)
- Number of participants with physical examination abnormalities(Up to 31 days)
- Maximum observed plasma concentration (Cmax)(Up to 29 days)
- Time of maximum observed plasma concentration (Tmax)(Up to 29 days)
- Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration(AUC(0-T))(Up to 29 days)
研究者
研究点 (3)
Loading locations...
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