Guerbet is starting a new clinical trial of gadopiclenol pharmacokinetics, safety and efficacy in children < 2 Years of Age.
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).
Inclusion will be performed using an age-down staggered approach. Three age groups will be defined: patients aged 3 to 23 months (inclusive); patients aged 28 days to less than 3 months; patients aged from birth to 27 days (term newborns). The inclusions will start with the oldest patients (Group 1) and end with the youngest patients (Group 3). A total of 3 blood samples per patient will be taken post-injection for PK analysis.
The clinical trial started in September 21, 2022 and will continue throughout July 31, 2023.
Simulated concentrations at 20 minutes post injection will be primary outcome measure. Determined from population PK.
The exclusion criteria, as well as contacts and locations can be found here: https://ichgcp.net/clinical-trials-registry/NCT05590884.