Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia (P03579)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 142
- 主要终点
- Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)
研究概览
简要总结
The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented or anticipated neutropenia expected to last at least 7 days and only in the following clinical situations: acute leukemia; myelodysplasia; severe aplastic anemia; autologous hematopoietic stem cell transplantation (HSCT) recipients; high risk neuroblastoma; advanced stage non-Hodgkin's lymphoma; recipients of allogeneic HSCT during the pre-engraftment (neutropenia) period
- •Participants of child-bearing potential must use a medically accepted method of
- •contraception throughout the study and for at least 30 days after stopping study medication, unless they are surgically or medically sterile or agree to remain abstinent.
排除标准
- •Proven invasive fungal infection (IFI) before study entry
- •Severe nausea and/or vomiting at screening
- •Received posaconazole within 10 days before screening
- •Unable to receive study drug by mouth or via an intestinal (enteral) tube
- •Females who are pregnant, intend to become pregnant during the study, or are breastfeeding
- •History of anaphylaxis attributed to the azole class of antifungal agents
研究组 & 干预措施
POS 12 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
干预措施: Posaconazole 12 mg/kg/day BID (Drug)
POS 12 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
干预措施: Posaconazole 12 mg/kg/day BID (Drug)
POS 18 BID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
干预措施: Posaconazole 18 mg/kg/day BID (Drug)
POS 18 BID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
干预措施: Posaconazole 18 mg/kg/day BID (Drug)
POS 18 TID 2 to <7 Years
Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
干预措施: Posaconazole 18 mg/kg/day TID (Drug)
POS 18 TID 7 to <18 Years
Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
干预措施: Posaconazole 18 mg/kg/day TID (Drug)
POS 12 TID 3 months to <2 Years
Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
干预措施: Posaconazole 12 mg/kg/day TID (Drug)
结局指标
主要结局
Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)
时间窗: Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)
Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to \<2 years of age weighing \<6.5 kg.
Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)
时间窗: Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose
Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to \<2500 ng/mL.
次要结局
- Number of Participants With an Adverse Event(Up to Day 58)
- Number of Participants With an Adverse Event Leading to Study Drug Discontinuation(Up to Day 28)