Phase 2
N=36
Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age
Central Nervous System Diseases · Pediatric Disorder · Body Indication
Bottom Line
View on ClinicalTrials.gov: NCT05590884 ↗Enrolled (actual)
36
Serious AEs
22.2%
Results posted
Oct 2025
Primary outcome: Primary: Area Under the Curve (AUCinf) — 392.3; 493.3 h.mg/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gadopiclenol (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUCinf) |
392.3; 493.3 | — |
| PRIMARY Elimination Half-life (t1/2α) |
0.3; 0.3 | — |
| PRIMARY Terminal Half-life (t1/2β) |
1.5; 2.1 | — |
| PRIMARY Gadopiclenol Concentrations 10 Min Post-injection (C10 Min) |
226.8; 190.4 | — |
| PRIMARY Gadopiclenol Concentration 20 Min Post-injection (C20 Min) |
161.5; 149.8 | — |
| PRIMARY Gadopiclenol Concentrations 30 Min Post-injection (C30 Min) |
109.4; 116.2 | — |
| PRIMARY Clearance |
0.128; 0.097 | — |
| PRIMARY Central Volume of Distribution (V1) |
0.176; 0.214 | — |
| PRIMARY Inter-compartment Clearance (Q) |
0.099; 0.123 | — |
| PRIMARY Peripheral Volume of Distribution (V2) |
0.066; 0.066 | — |
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).
Eligibility Criteria
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 [...]
Data sourced from ClinicalTrials.gov (NCT05590884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.