A Phase 1, Multicentre, Open-Label Study to Evaluate the PK, Safety, and Tolerability of a Single IV Dose of Rezafungin in Paediatric Subjects, Receiving Systemic Antifungals as Prophylaxis for IFI or to Treat a Suspected or Confirmed FI
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 10
- 主要终点
- Total Clearance (CL) of Rezafungin
研究概览
简要总结
This study aimed to learn what levels of rezafungin were in the blood after dosing and how safe it was, in children and adolescents below 18 years old who were already receiving treatment for a fungal infection, a suspected fungal infection or at risk of fungal infection.
The main question the researchers wanted to answer in this trial was:
• What were the levels of rezafungin in the blood after the participants were dosed? The researchers also wanted to know what medical problems happened during this trial.
The participants in this trial received one dose of rezafungin on day 1 through a needle into a vein, called an intravenous (IV) infusion. The dose of rezafungin was measured in milligrams (mg) and given to the participants according to their body weight in kilograms (mg/kg).
The doctors checked the participants' health and asked questions about what medications they were taking and took blood samples to check the levels of rezafungin in the participants' blood.
After receiving the treatment at day 30, the doctors checked the participants' health.
This was an "open-label" trial. This means each participant knew what they were receiving, and the doctors and trial staff also knew.
详细描述
To date, there are no clinical studies evaluating rezafungin in paediatric subjects.
The primary objective of the trial was to evaluate the pharmacokinetics (PK) of a single intravenous (IV) dose of rezafungin in paediatric participants from birth to < 18 years, receiving concomitant systemic antifungals as prophylaxis for invasive fungal infection (IFI) or to treat a suspected or confirmed fungal infection.
The secondary objective was to assess the safety and tolerability of a single IV dose of rezafungin in the subjects.
This is a Phase 1, multicentre, open-label, single-dose study. The study will be conducted at approximately 10 sites across at least 3 countries in Europe.
The study will be conducted in 3 parts:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female paediatric subjects from birth to <18 years of age who are receiving concomitant systemic antifungals (oral or IV) as prophylaxis for invasive fungal infection (IFI) or to treat a suspected or confirmed fungal infection.
排除标准
- •History of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals and/or excipients of this formulation
- •Previous or current medical conditions of severe ataxia, persistent tremors, intracranial hemorrhage or neuropathy, or a diagnosis of epilepsy, multiple sclerosis, or a movement disorder
- •Subjects with impaired renal or hepatic functions
- •Subjects with intestinal hypoxia, ischemia, necrosis, or necrotizing enterocolitis
- •Subject status is unstable
- •Subject is unlikely to complete required study procedures
- •Participation in another interventional treatment trial with an investigational agent or presence of an investigational device at the time of informed consent or within 28 days preceding the informed consent.
研究组 & 干预措施
Rezafungin
It is IMP.
干预措施: Rezafungin Acetate (Drug)
结局指标
主要结局
Total Clearance (CL) of Rezafungin
时间窗: End of infusion and 3-4, 6-8, 48, and 168 hours after start of infusion
Blood samples of 1 mL each were collected for the analysis of rezafungin plasma concentration. PK parameters were determined from the rezafungin concentration-time data using non-compartmental methods and actual sampling times.
Volume of Distribution of Rezafungin at Steady-state (Vss)
时间窗: End of infusion and 3-4, 6-8, 48, and 168 hours after start of infusion
Blood samples of 1 mL each were collected for the analysis of rezafungin plasma concentration. PK parameters were determined from the rezafungin concentration-time data using non-compartmental methods and actual sampling times.
Terminal Elimination Half-life of Rezafungin (t1/2)
时间窗: End of infusion and 3-4, 6-8, 48, and 168 hours after start of infusion
Blood samples of 1 mL each were collected for the analysis of rezafungin plasma concentration. PK parameters were determined from the rezafungin concentration-time data using non-compartmental methods and actual sampling times.
Maximum Observed Plasma Concentration (Cmax) of Rezafungin
时间窗: At end-of-infusion ± 15 minutes, then between 3 and 4 hours after start of infusion, between 6 and 8 hours after start of infusion, at 48 hours (± 4 hours) after start of infusion, and at 168 hours (± 12 hours) after start of infusion
Blood samples of 1 mL each were collected for the analysis of rezafungin plasma concentration. PK parameters were determined from the rezafungin concentration-time data using non-compartmental methods and actual sampling times.
Time at which the Cmax of Rezafungin Was Observed (Tmax)
时间窗: End of infusion and 3-4, 6-8, 48, and 168 hours after start of infusion
Blood samples of 1 mL each were collected for the analysis of rezafungin plasma concentration. PK parameters were determined from the rezafungin concentration-time data using non-compartmental methods and actual sampling times.
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) of Rezafungin
时间窗: End of infusion and 3-4, 6-8, 48, and 168 hours after start of infusion
Blood samples of 1 mL each were collected for the analysis of rezafungin plasma concentration. PK parameters were determined from the rezafungin concentration-time data using non-compartmental methods and actual sampling times.
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Rezafungin
时间窗: End of infusion and 3-4, 6-8, 48, and 168 hours after start of infusion
Blood samples of 1 mL each were collected for the analysis of rezafungin plasma concentration. PK parameters were determined from the rezafungin concentration-time data using non-compartmental methods and actual sampling times.
Apparent Volume of Distribution of Rezafungin During the Terminal Phase (Vz)
时间窗: End of infusion and 3-4, 6-8, 48, and 168 hours after start of infusion
Blood samples of 1 mL each were collected for the analysis of rezafungin plasma concentration. PK parameters were determined from the rezafungin concentration-time data using non-compartmental methods and actual sampling times.
次要结局
- Incidence of treatment-emergent adverse events (TEAEs)(From start of study on Day 1 to follow up Day 30 (+/- days))