A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Children (2-5 Years AND 6-11 Years) And Adolescents (12-16 Years) With Esophageal Candidiasis Or Other Invasive Candidiasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 13
- 主要终点
- PK parameters (AUCtau, Tmax, and Cmax)
研究概览
简要总结
Children with fungal infections will be divided into two groups by weight. Children weighing < 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than children weighing > 25 kg.
详细描述
This is a prospective, multicenter, open-label, repeat-dose study conducted in two groups. Subjects in Group 1 and Group 2 will receive treatment for 10 to 14 days (per investigator clinical judgment); dose level (3.0 mg/kg or 4.5 mg/kg) will be determined by the subject's weight at baseline. Study procedures in both groups will be similar except that serial blood samples for assessment of pharmacokinetics will be collected in Group 1. Subjects may only participate in one group of the study.
At least 24 subjects, with at least 8 in each of three age ranges, will be enrolled in Group 1 (PK + safety). At least 36 subjects will be enrolled in Group 2 (safety), with at least 12 in each of the three age ranges.
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
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 2 to 16 years inclusive
- •Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
- •Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables
排除标准
- •Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase > 5 times the upper limit of normal (ULN)
- •Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
- •Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
- •Subject has received treatment with an echinocandin within one week prior to first dosing
- •Subject status is unstable and subject is unlikely to complete all study required procedures
研究组 & 干预措施
1. Micafungin 3.0 mg
IV
干预措施: Micafungin (Drug)
2. Micafungin 4.5 mg
IV
干预措施: Micafungin (Drug)
结局指标
主要结局
PK parameters (AUCtau, Tmax, and Cmax)
时间窗: 10 - 14 Days
次要结局
- Adverse events(Day 1 to End of Study)
- Vital signs(Day 1 to End of Study)
- Hematology and chemistry laboratory tests(Day 1 to End of Study)
- 12-lead ECGs and Physical examination(Day 1 to End of Study)