Phase 1 Pharmacokinetics of Intravenous Nexium in Children

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate how much of repeated once daily intravenous (IV, meaning through a vein) doses of esomeprazole gets into the bloodstream of hospitalized children aged 0-17 years old that require acid suppression therapy.

Official Title
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A Phase I, Randomised, Open-label, Multi-National Study to Evaluate the Pharmacokinetics of Repeated Once-Daily Intravenous Doses of Esomeprazole in Paediatric Patients 0 to 17 Years Old, Inclusive.

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: parent/guardian must sign consent form and the child will be asked to sign and Assent Form if he/she is old enough and is able to sign verbal assent will be acceptable if the child is old enough to understand, but unable to write female and/or male hospitalized patients aged 0-17 years old who should be considered for treatment with acid suppressive therapy. Exclusion Criteria: female patients that are pregnant, or plan to become pregnant during the study period or is breast-feeding a child patients with a history of multiple drug allergies any illness, medical history, abnormal laboratory values, abnormal physical examination findings or abnormal vitals signs that could put the patient at risk when participating in the study

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Based on age and/or weight dose of esomeprazole IV qd in milligrams 20,40,10,20,10, 1.0 mg/kg, 0,5 mg/kg | Drug: esomeprazole<br>* IV qd for 4 days<br>* Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval |  | Day 4 of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole |  | Day 4 of study | 
| Safety and tolerability will be assessed by AEs, laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and ECG |  | Days 1-4 (during treatment), Days 1-28 (post treatment) | 
| Evaluate main metabolites of esomeprazole (sulphone metabolite and 5-hydroxy metabolite) by assessment of max plasma conc, total area under the plasma concentration vs time curve within a dosing interval, clearance scaled by fraction metabolised |  | Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, neonates