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Completed

NCT Number: NCT05590884

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).

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Key information

Conditions

Central Nervous System Diseases Body Indication Nervous System Diseases Pediatric Disorder

Age range

Up to 23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Országos Idegtudományi Intézet, Budapest, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • 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 [...]

Main 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 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 [...]

Treatment and study plan

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).

Other names: Elucirem

Primary outcomes

  1. Area Under the Curve (AUCinf)

    Time frame: 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)

    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

  2. Elimination Half-life (t1/2α)

    Time frame: 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).

    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

  3. Terminal Half-life (t1/2β)

    Time frame: 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).

    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

  4. Gadopiclenol Concentrations 10 Min Post-injection (C10 Min)

    Time frame: blood sample collection 10 minutes post-injection of gadopiclenol for analysis

    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

  5. Gadopiclenol Concentration 20 Min Post-injection (C20 Min)

    Time frame: blood sample collection 20 minutes post-injection of gadopiclenol

    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

  6. Gadopiclenol Concentrations 30 Min Post-injection (C30 Min)

    Time frame: blood sample collection 30 minutes post-injection of gadopiclenol

    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

  7. Clearance

    Time frame: 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).

    Individual predicted final model parameter scaled by body weight

  8. Central Volume of Distribution (V1)

    Time frame: 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).

    Individual predicted final model parameter scaled by body weight

  9. Inter-compartment Clearance (Q)

    Time frame: 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).

    Individual predicted final model parameter scaled by body weight

  10. Peripheral Volume of Distribution (V2)

    Time frame: 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).

    Individual predicted final model parameter scaled by body weight

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 21, 2022
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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