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
研究点 (1)
Loading locations...
相似试验
撤回
4 期
A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive AspergillosisAspergillosis/InvasiveAspergillosis/BloodNCT00423163Astellas Pharma Inc
已完成
3 期
An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal InfectionsFungemiaMycosesCandidiasisAspergillosisNCT00001810National Cancer Institute (NCI)300
已完成
2 期
Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary AspergillosisAllergic Bronchopulmonary AspergillosisNCT01621321Post Graduate Institute of Medical Education and Research, Chandigarh50
已完成
3 期
Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive AspergillosisAspergillosisNCT00531479Pfizer459
已完成
1 期
Drug-Drug Interaction (DDI) w/Ketoconazole or FluconazoleAlzheimer DiseaseNCT00860275Bristol-Myers Squibb30
