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

NCT05590884 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GDX-44-015
• Study Type: interventional
• Target: 36
• Locations: 3 countries
• Sites: 11

Brief 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).

Conditions

Central Nervous System Diseases; Pediatric Disorder; Body Indication

Outcome Measures

Primary Outcomes (10)

• 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).

Study Arms (3)

Age Group 1: patients aged 3 to 23 months

EXPERIMENTAL

One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.

Drug: Gadopiclenol

Age Group 2: patients aged 28 days to less than 3 months

EXPERIMENTAL

One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.

Drug: Gadopiclenol

Age Group 3: patients aged from birth to 27 days (term newborns)

EXPERIMENTAL

One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.

Drug: Gadopiclenol

Interventions

Gadopiclenol DRUG

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).

Also known as: Elucirem

Age Group 1: patients aged 3 to 23 months; Age Group 2: patients aged 28 days to less than 3 months; Age Group 3: patients aged from birth to 27 days (term newborns)

Eligibility Criteria

• Age: Up to 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[...\]

You may not qualify if:

• 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, \[...\]
• \. 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 \[...\]

Sponsors & Collaborators

• Guerbet: lead

Study Sites (11)

Cincinnatti Childrens Hospital

Cincinnati, Ohio, 45229, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-8908, United States

Location

Semmelweis Egyetem

Budapest, 1094, Hungary

Location

Országos Idegtudományi Intézet

Budapest, Hungary

Location

University of Debrecen Clinical Center Pediatric Department

Debrecen, Hungary

Location

Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza

Bydgoszcz, Poland

Location

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland

Location

Uniwersytecki Szpital Dzieciecy

Lublin, Poland

Location

Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej

Rzeszów, Poland

Location

Uniwersyteckie Centrum Kliniczne Warszawskiego

Warsaw, 02-091, Poland

Location

Instytut "Pomnik - Centrum Zdrowia Dziecka"

Warsaw, Poland

Location

MeSH Terms

Conditions

Central Nervous System Diseases

Interventions

gadopiclenol

Condition Hierarchy (Ancestors)

Nervous System Diseases

Limitations and Caveats

Due to incomplete recruitment in study GDX-44-015, with only 2 patients aged 28-89 days and none aged less than 28 days who could be included in the popPK analysis, exposure in these groups was only obtained by simulation using the final model.

Results Point of Contact

• Title: Frantz Hebert, Global Head of Clinical Development
• Organization: Guerbet

frantz.hebert@guerbet.com

+33 680249334

Study Officials

• Donna R Roberts, MD

  Medical University of South Carolina, Division of Neuroradiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: September 21, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 28, 2025
• Results First Posted: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); PL (6); HU (3)