An Open-label, Randomized, 2-treatment, 2-period, Crossover Study to Evaluate the Effect of Probenecid on the Pharmacokinetics of Pexidartinib in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax)
研究概览
简要总结
The primary objective of this trial is to assess the effect of probenecid on the pharmacokinetics (PK) of single-dose pexidartinib in healthy subjects.
Secondary objectives are to assess the safety and tolerability of pexidartinib alone and in combination with probenecid.
Participants will be confined to the clinic for approximately 32 days. Blood samples will be collected for PK analysis of pexidartinib and metabolites at predose and up to 312 hours (h) post dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is a healthy, nonsmoking person with a body mass index of 18 kg/m2 to 30 kg/m2 (inclusive) at Screening
- •Is willing to be confined at the clinic for approximately 32 days
- •Is surgically sterile or a naturally postmenopausal female and not lactating, or a male who agrees to use double barrier methods of contraception and avoid donating sperm from Check-in until 90 d after the final dose of pexidartinib
排除标准
- •Has any history or condition, per protocol or in the opinion of the investigator, that might compromise the participant's safety, their ability to complete the trial, and or analysis of results
研究组 & 干预措施
Pexidartinib then Probenecid
Participants receive Sequence AB: Treatment A (pexidartinib) first, then Treatment B (probenecid), with a washout period between them
干预措施: Pexidartinib (Drug)
Pexidartinib then Probenecid
Participants receive Sequence AB: Treatment A (pexidartinib) first, then Treatment B (probenecid), with a washout period between them
干预措施: Probenecid (Drug)
Probenecid then Pexidartinib
Participants receive Sequence BA: Treatment B (probenecid) first, then Treatment A (pexidartinib), with a washout period between them
干预措施: Pexidartinib (Drug)
Probenecid then Pexidartinib
Participants receive Sequence BA: Treatment B (probenecid) first, then Treatment A (pexidartinib), with a washout period between them
干预措施: Probenecid (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax)
时间窗: predose to 312 hours post dose
Maximum concentration of the drug and its metabolite in plasma
Time to Maximum Concentration (Tmax)
时间窗: within 312 hours post dose
Time at which the maximum concentration is reached
Area under the curve to the last quantifiable measurement (AUClast)
时间窗: within 312 hours post dose
Area under the drug concentration time curve from the first measurement to the last
次要结局
- Number of participants experiencing an adverse event(within 312 hours post dose)