Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age

Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 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).

Study Overview

• Status: Completed
• Conditions: Central Nervous System Diseases; Pediatric Disorder; Body Indication
• Intervention / Treatment: Drug: Gadopiclenol

Detailed Description

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.

A total of 3 blood samples per patient were taken post-injection for PK analysis.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1094
    • Semmelweis Egyetem
  • Budapest, Hungary
    • Országos Idegtudományi Intézet
  • Debrecen, Hungary
    • University of Debrecen Clinical Center Pediatric Department
• Poland
  • Bydgoszcz, Poland
    • Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza
  • Lodz, Poland
    • Instytut Centrum Zdrowia Matki Polki
  • Lublin, Poland
    • Uniwersytecki Szpital Dziecięcy
  • Rzeszów, Poland
    • Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej
  • Warsaw, Poland
    • Instytut "Pomnik - Centrum Zdrowia Dziecka"
  • Warsaw, Poland, 02-091
    • Uniwersyteckie centrum kliniczne Warszawskiego
• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnatti Childrens Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425-8908
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

1. 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,
2. Patient with known or highly suspected abnormalities/ lesion(s), scheduled to undergo contrast-enhanced MRI of any body region including CNS [...]

Main Exclusion Criteria:

1. 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,
2. 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,
3. 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, 10. 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, 11. Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker), 12. Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents [...]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Gadopiclenol; Patients will receive a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol will be administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW).; Other Names: Elucirem
Experimental: 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.	Drug: Gadopiclenol; Patients will receive a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol will be administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW).; Other Names: Elucirem
Experimental: 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.	Drug: Gadopiclenol; Patients will receive a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol will be administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW).; Other Names: Elucirem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUCinf)	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	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)
Elimination Half-life (t1/2α)	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	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).
Terminal Half-life (t1/2β)	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	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).
Gadopiclenol Concentrations 10 Min Post-injection (C10 Min)	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	blood sample collection 10 minutes post-injection of gadopiclenol for analysis
Gadopiclenol Concentration 20 Min Post-injection (C20 Min)	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	blood sample collection 20 minutes post-injection of gadopiclenol
Gadopiclenol Concentrations 30 Min Post-injection (C30 Min)	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	blood sample collection 30 minutes post-injection of gadopiclenol
Clearance	Individual predicted final model parameter scaled by body weight	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).
Central Volume of Distribution (V1)	Individual predicted final model parameter scaled by body weight	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).
Inter-compartment Clearance (Q)	Individual predicted final model parameter scaled by body weight	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).
Peripheral Volume of Distribution (V2)	Individual predicted final model parameter scaled by body weight	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).

Collaborators and Investigators

• Sponsor: Guerbet
• Investigators: Principal Investigator: Donna R Roberts, MD, Medical University of South Carolina, Division of Neuroradiology

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Central Nervous System Diseases; gadopiclenol
• Other Study ID Numbers: GDX-44-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No