NCT06318676已完成1 期
A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics of Mezigdomide (BMS-986348, CC-92480) in Adult Participants With Normal Renal Function, Severe Renal Impairment, and End-stage Renal Disease
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
- 26
- 试验地点
- 3
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 82 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A: Participants with severe renal impairment
Experimental
干预措施: Mezigdomide (Drug)
Group B: Participants with End Stage Renal Disease
Experimental
干预措施: Mezigdomide (Drug)
Group C: Participants with normal renal function
Experimental
干预措施: Mezigdomide (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Up to 24 days
Area under the plasma concentration-time curve (AUC)
时间窗: Up to 24 days
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T))
时间窗: Up to 24 days
次要结局
- Number of participants with adverse events (AEs)(Up to 54 days)
- Number of participants with serious adverse events (SAEs)(Up to 54 days)
- Number of participants with physical examination findings(Up to 24 days)
- Number of participants with vital sign abnormalities(Up to 24 days)
- Number of participants with 12-lead electrocardiogram (ECG) findings(Up to 24 days)
- Maximum observed concentration (Cmax)(Up to 24 days)
- Time of maximum observed concentration (Tmax)(Up to 24 days)
- Area under the plasma concentration-time curve (AUC)(Up to 24 days)
研究者
研究点 (3)
Loading locations...
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