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

Central Nervous System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590884
• Other study ID #: GDX-44-015
• Status: Recruiting
• Phase: Phase 2
• Start date: September 21, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: August 2023
• Source: Guerbet
• Contact: Camille Pitrou
• Phone: +33680249308
• Email: camille.pitrou[@]guerbet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

The inclusions in the three age groups will be completed in parallel. A total of 3 blood samples per patient will be taken post-injection for PK analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 23 Months

Eligibility

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 [...]

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Nervous System Diseases
• Pediatric Disorder

Intervention

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).

Locations

Country	Name	City	State
Bulgaria	Multiprofile Hospital for Active Treatment Central Onco Hospital	Plovdiv
Bulgaria	Acibadem City Clinic Tokuda Hospital	Sofia
Hungary	Országos Idegtudományi Intézet	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	University of Debrecen Clinical Center Pediatric Department	Debrecen
Poland	Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza	Bydgoszcz
Poland	Instytut Centrum Zdrowia Matki Polki	Lodz
Poland	Uniwersytecki Szpital Dzieciecy	Lublin
Poland	Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej	Rzeszów
Poland	Instytut "Pomnik - Centrum Zdrowia Dziecka"	Warszawa
Poland	Uniwersyteckie Centrum Kliniczne Warszawskiego	Warszawa
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cincinnatti Childrens Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Countries where clinical trial is conducted

United States,  Bulgaria,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simulated concentrations at 10 minutes post injection	Determined from population PK	Concentration is simulated at 10 minutes post injection
Primary	Simulated concentrations at 20 minutes post injection	Determined from population PK	Concentration is simulated at 20 minutes post injection
Primary	Simulated concentrations at 30 minutes post injection	Determined from population PK	Concentration is simulated at 30 minutes post injection
Primary	Area Under the Curve	Determined from population PK	A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Primary	Elimination half-life	Determined from population PK	A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Primary	Total clearance	Determined from population PK	A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Primary	Volume of distribution	Determined from population PK	A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).