A Multiple-Dose Study to Evaluate the Effects of Steady-State Tedizolid Phosphate Administration on the Pharmacokinetics and Safety of a Single Dose of Midazolam and Rosuvastatin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Area under the concentration versus time curve, from 0 to last observed/measured non-zero concentration (AUC0-t) of midazolam alone or in combination with tedizolid phosphate
研究概览
简要总结
The purpose of this study is to assess the effect of steady-state tedizolid phosphate on the single-dose pharmacokinetics of midazolam and rosuvastatin in healthy, adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy, adult males or females (women of non-childbearing potential)
- •continuous non-smokers who have not used nicotine-containing products for the previous 3 months
排除标准
- •mentally or legally incapacitated or has significant emotional problems
- •history or presence of clinically significant medical or psychiatric condition or disease
- •history or presence of alcoholism or drug abuse within the past 2 years
- •female participants who are pregnant, lactating, or of childbearing potential
- •donated blood or had significant blood loss within 56 days prior to first dose of study drug
- •plasma donation within 7 days prior to first dose of study drug
研究组 & 干预措施
Experimental Arm
Day 1: participants will receive midazolam (2 mg); Day 3: participants will receive rosuvastatin (10 mg); Days 5-13: participants will receive tedizolid phosphate (200 mg); Day 14: participants will receive tedizolid phosphate (200 mg) plus midazolam (2 mg); Day 15: participants will receive tedizolid phosphate (200 mg); Day 16: participants will receive tedizolid phosphate (200 mg) plus rosuvastatin (10 mg); Day 17: participants will receive tedizolid phosphate (200 mg)
干预措施: midazolam (Drug)
Experimental Arm
Day 1: participants will receive midazolam (2 mg); Day 3: participants will receive rosuvastatin (10 mg); Days 5-13: participants will receive tedizolid phosphate (200 mg); Day 14: participants will receive tedizolid phosphate (200 mg) plus midazolam (2 mg); Day 15: participants will receive tedizolid phosphate (200 mg); Day 16: participants will receive tedizolid phosphate (200 mg) plus rosuvastatin (10 mg); Day 17: participants will receive tedizolid phosphate (200 mg)
干预措施: rosuvastatin (Drug)
Experimental Arm
Day 1: participants will receive midazolam (2 mg); Day 3: participants will receive rosuvastatin (10 mg); Days 5-13: participants will receive tedizolid phosphate (200 mg); Day 14: participants will receive tedizolid phosphate (200 mg) plus midazolam (2 mg); Day 15: participants will receive tedizolid phosphate (200 mg); Day 16: participants will receive tedizolid phosphate (200 mg) plus rosuvastatin (10 mg); Day 17: participants will receive tedizolid phosphate (200 mg)
干预措施: tedizolid phosphate (Drug)
结局指标
主要结局
Area under the concentration versus time curve, from 0 to last observed/measured non-zero concentration (AUC0-t) of midazolam alone or in combination with tedizolid phosphate
时间窗: Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours
AUC0-t of rosuvastatin alone or in combination with tedizolid phosphate
时间窗: Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours
Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of midazolam alone or in combination with tedizolid phosphate
时间窗: Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours
AUC0-inf of rosuvastatin alone or in combination with tedizolid phosphate
时间窗: Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours
Maximum observed plasma concentration (Cmax) of midazolam alone or in combination with tedizolid phosphate
时间窗: Days 1 and 14: pre-dose, 0.25, 0.5, 1, 1.5, 3, 4.5, 6, 8, 12, 24 hours
Cmax of rosuvastatin alone or in combination with tedizolid phosphate
时间窗: Days 3 and 16: pre-dose, 1, 3, 4, 5, 6, 8, 16, 24, 36, 48 hours
次要结局
未报告次要终点