Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age
Status:
Recruiting
Trial end date:
2023-07-31
Target enrollment:
Participant gender:
Summary
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).