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临床试验/NCT06493409
NCT06493409已完成1 期

A Phase I, Two-part, Single-center, Open-label, Drug-drug Interaction Study to Assess the Effect of Voriconazole (Part 1) and Quinidine (Part 2) on the Pharmacokinetics of a Single Dose of Repotrectinib (BMS-986472) in Healthy Participants

Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年8月26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
入组人数
32
试验地点
1
主要终点
Maximum observed plasma concentration (Cmax)

研究概览

简要总结

The purpose of this study is to evaluate the effects of coadministration of voriconazole or quinidine on the pharmacokinetics (PK) of repotrectinib in healthy male and female (individual not of childbearing potential [INOCBP]) participants.

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 55 Years(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

Part 1

Experimental

干预措施: Repotrectinib (Drug)

Part 2

Experimental

干预措施: Repotrectinib (Drug)

Part 1

Experimental

干预措施: Voriconazole (Drug)

Part 2

Experimental

干预措施: Quinidine (Drug)

结局指标

主要结局

Maximum observed plasma concentration (Cmax)

时间窗: Up to Day 23

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 23

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

时间窗: Up to Day 23

次要结局

  • Cmax(Up to Day 23)
  • Number of participants with vital sign abnormalities(Up to Day 23)
  • Area under the plasma concentration-time curve over one dosing interval (AUC(TAU))(Up to Day 23)
  • Number of participants with Adverse Events (AEs)(Up to Day 52)
  • Number of participants with Severe Adverse Events (SAEs)(Up to Day 52)
  • Number of participants with physical examination abnormalities(Up to Day 23)
  • Apparent volume of distribution of terminal phase (Vz/F)(Up to Day 23)
  • Number of participants with electrocardiogram abnormalities(Up to Day 23)
  • Number of participants with clinical safety laboratory test abnormalities(Up to Day 22)
  • Apparent terminal phase half-life (T-HALF)(Up to Day 23)
  • Apparent total body clearance (CLT/F)(Up to Day 23)
  • Trough observed plasma concentration (Ctrough)(Up to Day 23)
  • Time of maximum observed plasma concentration (Tmax)(Up to Day 23)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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