Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI
Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI
This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with
 age-staggered approach.

 The primary objective is to evaluate the pharmacokinetic profile of P03277 in plasma
 following single intravenous injection of 0.05 mmol/kg body weight in pediatric population
 aged from 2 to 17 years.
A population PK approach and an age-down staggered approach will be used. Patients will be
 recruited into 3 predefined age groups: 12-17, 7-11 and 2-6 years. The inclusions will start
 with the older group (Adolescents, 12-17 years), followed by Preadolescents (7-11 years) and
 finally Young Children (2-6 years of age).
Inclusion Criteria:

 -  Female or male pediatric patient aged 2 to 17 years,

 -  Patient scheduled to undergo routine Central Nervous System contrast-enhanced MRI,

 -  Patient whose parent(s) or legal guardian (where applicable) having read the
 information provided his/her/their consent to patient's participation in writing by
 dating and signing the informed consent prior to any trial related procedure being
 conducted,

 -  Patient with capacity of understanding who received age- and maturity-appropriate
 information and provided his/her assent to participate in the trial (as required by
 national regulations),

 Exclusion Criteria:

 -  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 1 day after P03277 administration,

 -  Patient whose preceding to P03277 administration or subsequent treatment or procedure
 (e.g., diuretics, clinically significant blood loss or blood transfusion) would alter
 P03277 pharmacokinetic parameters,

 -  Patient with acute or chronic renal insufficiency defined as estimated Glomerular
 Filtration Rate (eGFR) out of age-adjusted normal values [eGFR must be calculated
 based on bedside Schwartz equation],

 -  Patient with history of bleeding disorder,

 -  Patient with known severe liver disease,

 -  Patient with known cardiac disease (e.g., heart rhythm anomalies, long QT syndrome),

 -  Patient with any clinically significant abnormal 12-lead ECG that in the
 Investigator's opinion would affect the safety evaluation or place the patient at
 risk,

 -  Patient with electrolyte or fluid imbalance that at Investigator's judgment presents
 undue risk assessed within 1 month prior to P03277 administration,

 -  Patient undergoing a change in chemotherapy within 1 day prior to or 1 day after
 P03277 administration,

 -  Patient who received or will receive any other contrast agent for CT and/or MRI within
 1 week prior to or 1 week after P03277 administration,

 -  Pregnant or breast-feeding female patient [female patient with childbearing potential
 (who experienced menarche) must have a negative urine pregnancy test within 24 hours
 prior to P03277 administration and must be using medically approved contraception if
 sexually active].