An Open-Label, Single Dose, Pharmacokinetic Study of AL-60371 Otic Suspension, 0.3% in Pediatric Subjects Following Tympanostomy Tube Surgery
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Maximum observed analyte plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to describe the pharmacokinetics of AL-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requires bilateral myringotomy and tympanostomy tube insertion;
- •Provides informed consent (parent/legal guardian);
- •Signs assent form where applicable (subject);
- •Accompanied by parent/legal guardian at each visit;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Menarcheal females;
- •Current or recent history of any disease which, in the opinion of the Principal Investigator, may place the subject at risk or interfere with study;
- •Use of excluded medications within one week prior to surgery and for the duration of the study;
- •Requires another surgical procedure in addition to the myringotomy;
- •Clinically relevant otic condition which, in the opinion of the Principal Investigator, would preclude the safe administration of the study medication;
- •Participation in any other investigational study within 30 days before entry into this study or along with this study;
- •Known or suspected allergy or hypersensitivity to any active or inactive ingredient in the test article;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-60371/Posology 1
AL-60371 otic suspension, single dose of 200 µL following surgical insertion of tympanostomy tubes
干预措施: AL-60371 otic suspension (Drug)
AL-60371/Posology 2
AL-60371 otic suspension, single dose of 4 drops following surgical insertion of tympanostomy tubes
干预措施: AL-60371 otic suspension (Drug)
结局指标
主要结局
Maximum observed analyte plasma concentration (Cmax)
时间窗: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).
Time to reach Cmax (Tmax)
时间窗: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).
Area under the analyte plasma concentration-time curve to the last quantifiable sampling time point (AUC0-last)
时间窗: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).
Area under the concentration-time curve from 0 to infinity (AUC0-∞)
时间窗: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).
Time to last measurable concentration (Tlast)
时间窗: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).
The terminal elimination half (T½)
时间窗: Day 1/Surgery Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6 hours post-dose
The analyte plasma concentrations at each collection time point will be quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS).
次要结局
未报告次要终点