Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Cmax of midazolam.
研究概览
简要总结
Drug: 2 single oral doses of midazolam, 2 single oral doses of prednisolone , and clofutriben once daily for 16 days.
详细描述
Approximately 16 healthy male and female participants will be enrolled at a single center in the US. Each participant will receive 2 single oral doses of midazolam , 2 single oral doses of prednisolone, and clofutriben once daily for 16 days. On each day that midazolam is administered, blood samples for midazolam analysis in plasma will be collected for 24 hours. On each day that prednisolone is administered, blood samples for prednisolone, prednisone, and 6β-hydroxyprednisolone analyses in plasma will be collected for 24 hours.
Blood samples for clofutriben and metabolite (AS2570469) analyses in plasma will be collected for 24 hours after the first dose and during 2 intervals at steady state. Blood samples for cortisol and cortisone analyses will be collected for 24 hours after administration of prednisolone, clofutriben, and both trial interventions together, and prior to dosing of either trial intervention. Urine will be collected for analysis of clofutriben, prednisolone, and metabolites. Feces will be collected for analysis of clofutriben and metabolites. Safety and tolerability will be assessed.
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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants aged 18 to 75 years of age,
- •Body mass index of 18 to 35 kg/m2,
- •Taking no medications,
- •Are considered by the investigator to be in good general health.
排除标准
- •In the opinion of the investigator, the participant is not suitable for entry into the trial or has any contraindication to midazolam or prednisolone.
研究组 & 干预措施
2 single oral doses of prednisolone
2 single oral doses of prednisolone
干预措施: 2 single oral doses of prednisolone (Drug)
clofutriben once daily for 16 days
clofutriben once daily for 16 days
干预措施: clofutriben once daily for 16 days (Drug)
Experimental: midazolam
Drug: 2 single oral doses of midazolam
干预措施: midazolam (Drug)
结局指标
主要结局
Cmax of midazolam.
时间窗: 24 hours from dose
It will be concluded that there is no relevant interaction of clofutriben on midazolam if the 90% CIs for the Cmax ratios (midazolam + clofutriben)/midazolam alone) are contained within the \[80%, 125%\] interval.
AUC0-t of midazolam
时间窗: 24 hours from dose
: It will be concluded that there is no relevant interaction of clofutriben on midazolam if the 90% CIs for the AUC0-t (midazolam + clofutriben)/midazolam alone) are contained within the \[80%, 125%\] interval.
次要结局
未报告次要终点