Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Inclusion will be performed using an age-down staggered approach. Three age groups will be defined:
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Group 1: patients aged 3 to 23 months (inclusive)
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Group 2: patients aged 28 days to less than 3 months;
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Group 3: patients aged from birth to 27 days (term newborns). The inclusions will start with the oldest patients (Group 1) and end with the youngest patients (Group 3). A total of 3 blood samples per patient will be taken post-injection for PK analysis.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Age Group 1: patients aged 3 to 23 months One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients. |
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).
Other Names:
|
| Experimental: Age Group 2: patients aged 28 days to less than 3 months One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients. |
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).
Other Names:
|
| Experimental: Age Group 3: patients aged from birth to 27 days (term newborns) One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients. |
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).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Simulated concentrations at 10 minutes post injection [Concentration is simulated at 10 minutes post injection]
Determined from population PK
- Simulated concentrations at 20 minutes post injection [Concentration is simulated at 20 minutes post injection]
Determined from population PK
- Simulated concentrations at 30 minutes post injection [Concentration is simulated at 30 minutes post injection]
Determined from population PK
- Area Under the Curve [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).]
Determined from population PK
- Elimination half-life [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).]
Determined from population PK
- Total clearance [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).]
Determined from population PK
- Volume of distribution [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).]
Determined from population PK
Eligibility Criteria
Criteria
Main Inclusion Criteria:
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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,
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Patient with known or highly suspected abnormalities/ lesion(s) as detected by previous imaging examinations (including the fetal imaging, scheduled to undergo contrast-enhanced MRI of any body region including CNS [...]
Main Exclusion Criteria:
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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,
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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,
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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, [...]
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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 [...]
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cincinnatti Childrens Hospital | Cincinnati | Ohio | United States | 45229 |
| 2 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425-8908 |
| 3 | Multiprofile Hospital for Active Treatment Central Onco Hospital | Plovdiv | Bulgaria | ||
| 4 | Acibadem City Clinic Tokuda Hospital | Sofia | Bulgaria | ||
| 5 | Semmelweis Egyetem | Budapest | Hungary | 1094 | |
| 6 | Országos Idegtudományi Intézet | Budapest | Hungary | ||
| 7 | University of Debrecen Clinical Center Pediatric Department | Debrecen | Hungary | ||
| 8 | Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza | Bydgoszcz | Poland | ||
| 9 | Instytut Centrum Zdrowia Matki Polki | Lodz | Poland | ||
| 10 | Uniwersytecki Szpital Dzieciecy | Lublin | Poland | ||
| 11 | Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej | Rzeszów | Poland | ||
| 12 | Instytut "Pomnik - Centrum Zdrowia Dziecka" | Warszawa | Poland |
Sponsors and Collaborators
- Guerbet
Investigators
- Principal Investigator: Donna R Roberts, MD, Medical University of South Carolina, Division of Neuroradiology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GDX-44-015