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

NCT05590884 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-10-28

Study results available
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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

Interventions

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).

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Donna R Roberts, MD · Medical University of South Carolina, Division of Neuroradiology

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
23 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2024-09-30
Completion
2024-09-30
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05590884 on ClinicalTrials.gov