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临床试验/NCT06318676
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

Celgene3 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年3月21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
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

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

发起方
Celgene
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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