Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 36
- 试验地点
- 11
- 主要终点
- Peripheral Volume of Distribution (V2)
研究概览
简要总结
This Phase II open-label, uncontrolled, multicenter trial is designed to investigate the pharmacokinetic (PK) profile of gadopiclenol in plasma, in pediatric patients aged up to 23 months inclusive (term neonates or preterm infants after the neonatal period), using a population PK approach.
Primary objective is to evaluate the PK profile of gadopiclenol in plasma following single intravenous injection of 0.05 mmol/kg body weight (BW) in pediatric population aged up to 23 months (inclusive) scheduled for a contrast-enhanced MRI examination of any body region including central nervous system (CNS).
详细描述
Three age groups are defined:
- Group 1: patients aged 3 to 23 months (inclusive)
- Group 2: patients aged 28 days to less than 3 months;
- Group 3: patients aged from birth to 27 days (term newborns).
At study set-up, the inclusions started with the oldest patients in group 1 and using an age-down staggered approach.
The decision to start the inclusions in group 2 was taken by the Trial Safety Review Board based on safety assessment over one-day period after injection of the first 13 patients in group 1.
According to the protocol version 4 (amendments 2 & 3), the age-down staggered approach was discontinued to allow the inclusions in Group 3 (patients aged from birth to 27 days), simultaneously to inclusions in group 1 and group 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male pediatric patient aged from birth to 23 months of age inclusive (term neonates for all age groups or preterm infants after the neonatal period for groups 1 or 2). The neonatal period for preterm newborns is defined as the day of birth through the expected date of delivery plus 27 days. Term is defined as ≥37 completed weeks of amenorrhea,
- •Patient with known or highly suspected abnormalities/ lesion(s), scheduled to undergo contrast-enhanced MRI of any body region including CNS [...]
排除标准
- •Patient planned for treatment or procedure (e.g. surgery) that would prevent from obtaining the required blood samples or performing other trial procedures between the screening visit and up to one day after gadopiclenol administration,
- •Patient undergoing treatment or procedure (e.g., diuretics, clinically significant blood loss or blood transfusion) preceding or subsequent to gadopiclenol administration that would alter gadopiclenol pharmacokinetic parameters,
- •Patient with acute or chronic renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) out of age-adjusted normal value calculated based on bedside Schwartz equation, [...]
- •9. Patient undergoing a change in chemotherapy (product or dosage) within one day prior to or one day after gadopiclenol administration,
- •Patient who received or will receive any other contrast agent for CT and/or MRI within one week prior to or one week after gadopiclenol administration,
- •Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker),
- •Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents [...]
研究组 & 干预措施
Age Group 1: patients aged 3 to 23 months
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
干预措施: Gadopiclenol (Drug)
Age Group 2: patients aged 28 days to less than 3 months
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
干预措施: Gadopiclenol (Drug)
Age Group 3: patients aged from birth to 27 days (term newborns)
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
干预措施: Gadopiclenol (Drug)
结局指标
主要结局
Peripheral Volume of Distribution (V2)
时间窗: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Individual predicted final model parameter scaled by body weight
Area Under the Curve (AUCinf)
时间窗: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours)
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Elimination Half-life (t1/2α)
时间窗: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Terminal Half-life (t1/2β)
时间窗: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Gadopiclenol Concentrations 10 Min Post-injection (C10 Min)
时间窗: blood sample collection 10 minutes post-injection of gadopiclenol for analysis
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Gadopiclenol Concentration 20 Min Post-injection (C20 Min)
时间窗: blood sample collection 20 minutes post-injection of gadopiclenol
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Gadopiclenol Concentrations 30 Min Post-injection (C30 Min)
时间窗: blood sample collection 30 minutes post-injection of gadopiclenol
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Clearance
时间窗: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Individual predicted final model parameter scaled by body weight
Central Volume of Distribution (V1)
时间窗: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Individual predicted final model parameter scaled by body weight
Inter-compartment Clearance (Q)
时间窗: A total of 3 blood samples per patient were collected post-injection of gadopiclenol for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Individual predicted final model parameter scaled by body weight
次要结局
未报告次要终点