NCT06425198已完成1 期
A Phase 1, Multi-center, Open-label Study to Assess the Pharmacokinetics and Safety of BMS-986278 in Healthy Participants and Those With Mild, Moderate and Severe Hepatic Impairment
Bristol-Myers Squibb4 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年6月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
The purpose of this study is to assess the drug levels and safety of BMS-986278 in participants with mild, moderate, and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Participants:
- •Must have a body mass index (BMI) between 18 and 40 kg/m^2 (inclusive), and body weight ≥ 50 kg.
- •Mild, Moderate, or Severe Hepatic Impairment Participants:
- •Mild, moderate, or severe hepatic impairment (HI) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
- •Mild, moderate, and severe HI participants will be enrolled according to the Child-Pugh classification score.
- •Matched Healthy Participants:
- •Free of any clinically significant disease that would interfere with the study evaluations.
- •Normal hepatic function participants will be enrolled and matched individually with HI participants with respect to age (± 10 years), weight (± 20%), sex, and race/ethnicity (Japanese and Chinese participants vs non-Japanese and non-Chinese participants).
排除标准
- •All Participants:
- •History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women, or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
- •Must not have had any prior exposure to BMS-
- •Mild, Moderate, or Severe Hepatic Impairment Participants:
- •Acute liver disease (eg, caused by an acute infection or drug toxicity).
- •History of initial stage/planned liver transplantation within 6 months of screening or has received a liver transplant.
- •Matched Healthy Participants:
- •Any significant medical condition, or psychiatric illness that would prevent participant from participating in the study.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Group A: Mild Hepatic Impairment BMS-986278
Experimental
干预措施: BMS-986278 (Drug)
Group B: Moderate Hepatic Impairment BMS-986278
Experimental
干预措施: BMS-986278 (Drug)
Group C: Severe Hepatic Impairment BMS-986278
Experimental
干预措施: BMS-986278 (Drug)
Group D: Normal Hepatic Function BMS-986278
Experimental
干预措施: BMS-986278 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Up to day 9
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
时间窗: Up to day 9
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
时间窗: Up to day 9
次要结局
- Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u](Up to day 9)
- Incidence of serious adverse events (SAEs)(Up to 62 days)
- Maximum observed plasma concentration of unbound drug (Cmax_u)(Up to day 9)
- Incidence of adverse events (AEs)(Up to 62 days)
- Time of maximum observed concentration (Tmax)(Up to day 9)
- Apparent body clearance (CLT/F)(Up to day 9)
- Number of participants with clinical laboratory abnormalities(Up to 62 days)
- Terminal elimination half-life (T-HALF)(Up to day 9)
- Number of participants with physical examination abnormalities(Up to 62 days)
- Number of participants with vital sign abnormalities(Up to 62 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 62 days)
- Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration of unbound drug [AUC(0-T)_u](Up to day 9)
研究者
研究点 (4)
Loading locations...
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