Pharmacometric Modeling of a Hospital Preparation

NCT07372560 | Not Yet Recruiting

• 2 other identifiers: 2022/0354/OBN° IDRCB : 2025-A01969-40
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric prescribers are very often faced with a lack of suitable therapies, particularly oral ones. This represents a major public health problem and necessitates adjustments to dosage or pharmaceutical form using medications marketed for adults, some of which contain excipients that may be harmful to children. This creates risks of dilution errors, administration errors, and the occurrence of adverse effects. Hospital pharmacy technicians are called upon daily to provide appropriate treatment for children. However, although this activity is authorized (Public Health Code, Good Preparation Practices), pharmacokinetic/pharmacodynamic studies on these preparations are only exceptionally carried out. Indeed, only stability studies are required to determine the expiration date of the preparation. Thus, prescribers are left without the necessary information to choose the dosage and administration schedule. Pediatric dosages are extrapolated from those for adults without any certainty of the treatment's effectiveness.

Conditions

Hypertensive Patients

Keywords

Pharmacometric modeling; hématologie-oncologie pédiatrique

Outcome Measures

Primary Outcomes (10)

• Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (Area Under the Curve (AUC)).

  This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.

  24 hours

• Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (apparent distribution volume (Vd/F)).

  This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.

  24 hours

• Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (apparent clearance (Cl/F)).

  This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.

  24 hours

• Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (maximum concentration (Cmax)).

  This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.

  24 hours

• Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (time to reach this concentration (Tmax)).

  This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.

  24 hours

• Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (elimination constant (ke)).

  This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.

  24 hours

• Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (elimination half-life (t1/2)).

  This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.

  24 hours

• Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (clairance inter-compartimentale apparente (Q/F)).

  This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.

  24 hours

• Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (apparent central volume (Vc/F)).

  This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.

  24 hours

• Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (apparent peripheral volume (Vp/F)).

  This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.

  24 hours

Secondary Outcomes (9)

• Describe the distribution of the residual concentration at 24 hours

  24 hours

• Demographic parameters of the studied population: sex

  24 hours

• Demographic parameters of the studied population: age

  24 hours

• Demographic parameters of the studied population: weight .

  24 hours

• Demographic parameters of the studied population: height.

  24 hours

Interventions

Evaluation of the pharmacokinetic parameters of an oral formulation of nicardipine hydrochloride OTHER

These pharmacokinetic parameters aim to optimize the use of this preparation in the management of pediatric hypertension. The pharmacokinetic parameters are: the area under the curve (AUC), the apparent volume of distribution (Vd/F), the apparent clearance (Cl/F), the maximum concentration (Cmax), the time to reach this concentration (Tmax), the elimination constant (ke), the elimination half-life (t1/2), the apparent intercompartmental clearance (Q/F), the apparent central volume (Vc/F), and the apparent peripheral volume (Vp/F). This kinetic profile will be obtained using Monolix® software modeling with the results of validated blood sampling methods. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children in pediatric hematology-oncology requiring nicardipine administration as part of their standard care whether or not they are nicardipine-naïve (switching from the intravenous form used for hypertensive emergencies to the oral form, or patients already receiving hospital-prepared nicardipine oral solution at 2 mg/mL)

You may qualify if:

• Patients aged 1 to 15 years, male or female.
• Patients followed in pediatric hematology-oncology.
• Patients with a central venous catheter as part of their initial care and available for blood sampling.
• Patients with a prescription for oral nicardipine (oral solution) whose formulation and/or dosage is/are not compatible with the commercial form of Loxen® 20 mg, requiring preparation.
• Patients requiring oral administration of nicardipine every 8 hours (initial prescription or renewal).
• Patients covered by a social security scheme.
• Parents/guardians informed of the study and not objecting to their child's participation
• For minors old enough to understand: patients who have not objected to the research.

You may not qualify if:

• Patient n'ayant pas un schéma d'administration toutes les 8 heures.
• Hypersensibilité à la substance active.
• Antécédent d'allergie à l'un des excipients (polysorbate 80, hypromellose, saccharine sodique, sorbate de potassium, acide citrique, citrate de sodium, saccharose).
• Refus de participation de l'enfant, des parents ou du représentant légal.

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collection of 6 x 1 mL tubes of plasma via functional catheter for nicardipine assay (collection before dose #1, then 30 minutes, 2 hours, 4 hours, 8 hours, and 24 hours after dose #1)

Study Officials

• Marine MC CAVELIER, Doctor

  University Rouen Hospital

  STUDY DIRECTOR

• Thomas TD DUFLOT, Doctor

  University Rouen Hospital

  STUDY CHAIR

Central Study Contacts

Delphine DP PICOCHE, Director

CONTACT

02 32 88 82 65; delphine.picoche@chu-rouen.fr

Vincent VF FERRANTI, ARC

CONTACT

02 32 88 82 65; vincent.ferranti@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 28, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 28, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)