NCT06535399已完成1 期
A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of Golcadomide (BMS-986369) in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
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
- Celgene
- 入组人数
- 29
- 试验地点
- 7
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to assess the drug levels and safety of golcadomide (BMS-986369) in adult participants with 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
- •for all Participants (Group A, Group B, Group C):
- •Body mass index (BMI) between 18 and 40 kg/m^2 (inclusive), and body weight ≥ 50 kg.
- •Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group A and Group B):
- •Participants have moderate HI (Group A), severe HI (Group B) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
- •Participants have moderate (Group A) or severe (Group B) HI as defined by National Cancer Institute-Organ Dysfunction Working Group (NCI-ODWG) criteria.
- •Inclusion Criteria for a Matched Healthy Participant (Group C):
- •Participants must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions as agreed by the investigator and the Sponsor Medical Monitor.
- •Participants must be free of any clinically significant disease that would interfere with the study evaluations.
排除标准
- •for all Participants (Group A, Group B, and Group C):
- •Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).
- •History of major surgery within 8 weeks before the study intervention administration.
- •Any other clinically significant medical, psychiatric, and/or social reason, or other active issues, as determined by the investigator.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Group A: BMS-986369 Moderate Hepatic Impairment
Experimental
干预措施: BMS-986369 (Drug)
Group B: BMS-986369 Severe Hepatic Impairment
Experimental
干预措施: BMS-986369 (Drug)
Group C: BMS-986369 Normal Hepatic Function
Experimental
干预措施: BMS-986369 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to approximately 44 days
Time of maximum observed plasma concentration (Tmax)
时间窗: Up to approximately 44 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
时间窗: Up to approximately 44 days
次要结局
- Incidence of adverse events (AEs)(Up to approximately 44 days)
- Incidence of serious adverse events (SAEs)(Up to approximately 44 days)
- Number of participants with physical examination abnormalities(Up to approximately 44 days)
- Number of participants with vital sign abnormalities(Up to approximately 44 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to approximately 44 days)
- Number of participants with clinical safety laboratory test abnormalities(Up to approximately 44 days)
研究者
研究点 (7)
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