A Phase 1, Open-label, Multicenter Study to Determine the Pharmacokinetics and Safety of Intravenous Eravacycline in Children With Suspected or Confirmed Bacterial Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 7
- 主要终点
- Assess the Pharmacokinetics (PK) parameters for CL, systemic clearance
研究概览
简要总结
This is a Phase 1, open-label, multi-center study to determine the pharmacokinetics and safety of intravenous Eravacycline in Children with Suspected or Confirmed Bacterial Infection. Male and Female subjects from 8 to <18 years of age who fulfill the inclusion/exclusion criteria will be enrolled in this study.
详细描述
This is a Phase 1, open-label, single dose study to evaluate PK, safety, and tolerability of IV eravacycline in children with suspected or confirmed bacterial infection who are receiving systemic antibiotic therapy, other than eravacycline. The study design will allow for evaluation of PK and safety of IV eravacycline in a pediatric population at exposures predicted to be comparable to those already studied in adults. The study design is depicted in Figure 1.
Two cohorts defined by age group will be enrolled simultaneously:
- Cohort 1: 12 to <18 years of age (adolescents)
- Cohort 2: 8 to <12 years of age (younger children) Eravacycline will be administered as a single IV dose using the optimum dosage determined from PK-PD modeling and model-based simulations of phase 1, 2, and 3 adult data. Blood samples will be collected for PK analysis at predetermined timepoints.
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
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female from 8 to <18 years of age on the day informed consent (and assent, if applicable) is obtained
- •Written informed consent from parent(s) or other legally authorized representative(s) and informed assent from subject (if age appropriate according to local requirements)
- •Hospitalized, in stable condition, and receiving or plan to receive within 24 hours systemic antibiotic therapy, other than eravacycline, for a suspected or confirmed bacterial infection
- •Likely to survive the current illness
- •In the Investigator's opinion, the subject will require hospitalization for at least 24 hours following administration of the study drug
- •The subject appears to have sufficient intravascular access (peripheral or central) to receive study drug
排除标准
- •Evidence or history of a clinically significant medical condition that may, in the assessment of the Investigator, impair study participation or pose a significant safety risk or diminish the subject's ability to undergo all study procedures and assessments
- •Received an investigational product and/or device within 30 days prior to study drug administration or is currently enrolled in any other clinical study involving an investigational product or any other type of medical treatment judged by the Investigator, in consultation with the Medical Monitor, not to be scientifically or medically compatible with this study
- •History of hypersensitivity to tetracycline antibiotics
- •Prior dosing in this protocol
- •Unlikely to survive at least 48 hours following administration of study drug
- •Unable or unwilling, in the judgment of the Investigator, to comply with the protocol
- •Subject is a child of an employee of the Investigator or study center who has direct involvement in the proposed study or other studies under the direction of the same Investigator or study center, or an immediate family member of the employee or the Investigator, defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- •Breastfeeding females
- •Females of childbearing potential [those with menarche and/or thelarche (beginning of breast development)] and sexually active males who are unwilling or unable to use an acceptable method of contraception
- •Positive pregnancy test in females of childbearing potential
- •Any other circumstance that, in the opinion of the Investigator, would preclude subject participation in the study
研究组 & 干预措施
Cohort 1
Eravacycline (TP-434) intravenous formulation Eravacycline will be administered as a single 60 minute IV infusion according to age.
Age group (years) Dose (mg/kg) 12 to <18 (Cohort 1) 1.50
干预措施: Eravacycline (TP-434) (Drug)
Cohort 2
Eravacycline will be administered as a single 60 minute IV infusion according to age.
Age group (years) Dose (mg/kg) 8 to <12 (Cohort 2) 1.75
干预措施: Eravacycline (TP-434) (Drug)
结局指标
主要结局
Assess the Pharmacokinetics (PK) parameters for CL, systemic clearance
时间窗: Screening (-2 to 1) to Day 7
CL, systemic clearance
Assess the Pharmacokinetics (PK) parameters for Vd, volume of distribution
时间窗: Screening (-2 to 1) to Day 7
Vd, volume of distribution
Assess the Pharmacokinetics (PK) parameters for AUC0-t, area under the plasma concentration-time curve
时间窗: Screening (-2 to 1) to Day 7
AUC0-t, area under the plasma concentration
Assess the Pharmacokinetics (PK) parameters for Cmax, maximum observed plasma concentration
时间窗: Screening (-2 to 1) to Day 7
Cmax, maximum observed plasma concentration
Assess the Pharmacokinetics (PK) parameters for AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
时间窗: Screening (-2 to 1) to Day 7
AUC0-24, area under the plasma concentration-time curve from time 0 to 24 hours after dose
Assess the Pharmacokinetics (PK) parameters for t1/2, elimination half-life
时间窗: Screening (-2 to 1) to Day 7
t1/2, elimination half-life
Assess the Pharmacokinetics (PK) parameters for Clast,, last observed plasma concentration
时间窗: Screening (-2 to 1) to Day 7
Clast, last observed plasma concentration
Assess the Pharmacokinetics (PK) parameters for AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
时间窗: Screening (-2 to 1) to Day 7
AUC0-inf, area under the plasma concentration-time curve extrapolated to infinite time
次要结局
- Adverse Events(From the time of signing the informed consent form to Day 7)
- Vital Signs including blood pressure(Screening (-2 to 1) to Day 7)
- Vital Signs including respiratory rate(Screening (-2 to 1) to Day 7)
- Vital Signs including body temperature(Screening (-2 to 1) to Day 7)
- A Directed Physical examination including chest/respiratory(Screening (-2 to 1) to Day 7.)
- A Directed Physical examination including heart/cardiovascular(Screening (-2 to 1) to Day 7.)
- Vital Signs including heart rate(Screening (-2 to 1) to Day 7)
- Safety laboratory results including clinical chemistry(Screening (-2 to 1) to Day 7)
- Safety laboratory tests including hematology(Screening (-2 to 1) to Day 7)