NCT07763418尚未招募1 期
A Phase 1, Multi-center, Single-dose, Open-label Study to Evaluate the Pharmacokinetics and Safety of Golcadomide (BMS-986369) in Participants With Severe Renal Impairment and End-Stage Renal Disease Compared With Participants With Normal Renal Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics and safety of golcadomide (BMS-986369) in matched healthy participants with normal renal function, adult participants with severe renal impairment, and participants with end-stage renal disease.
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must have severe renal impairment (RI).
- •Participant must have end-stage renal disease (ESRD).
- •Participant must be healthy male and female participants not of childbearing potential between 18 and 84 years of age (inclusive) with a BMI between 18 and 40 kg/m2, (inclusive) at screening.
排除标准
- •Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion (ADME).
- •Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study
- •Known or suspected active autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Group A
Experimental
干预措施: Golcadomide (Drug)
Group B
Experimental
干预措施: Golcadomide (Drug)
Group C
Experimental
干预措施: Golcadomide (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Up to Day 44
Maximum observed concentration (Cmax)
时间窗: Up to Day 44
Time of maximum observed plasma concentration (Tmax)
时间窗: Up to Day 44
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 44
次要结局
- Number of participants with adverse events (AEs)(Up to Day 60)
- Number of participants with serious adverse events (SAEs)(Up to Day 60)
- Number of participants with physical examination (PE) abnormalities(Up to Day 44)
- Number of participants with vital sign abnormalities(Up to Day 44)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 44)
- Number of participants with clinical safety laboratory abnormalities(Up to Day 44)
- Dialysate clearance of golcadomide from plasma (CLD)(Day 1)
研究者
研究点 (3)
Loading locations...
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