Phase 1 Pharmacokinetics of Intravenous Nexium in Children

Condition(s) targeted: Pharmacokinetics

Intervention: esomeprazole (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Kurt Brown, MD, Study Director, Affiliation: AstraZeneca
Per Lundborg, MD, Study Director, Affiliation: AstraZeneca
Jill McGuinn, Study Director, Affiliation: AstraZeneca

Overall contact:
AstraZeneca Cinical Study, Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com

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: 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.

Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study

Primary outcome: Pharmacokinetic-area under plasma concentration versus time curve within a dosing interval

Secondary outcome:

Maximum plasma concentration, total, plasma clearance, steady-state volume of distribution of esomeprazole

Safety and tolerability will be assessed by AEs, laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and ECG

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

Minimum age: N/A. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

AstraZeneca Cinical Study, Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com

Research Site, BUDAPEST, Hungary; Active, not recruiting

Research Site, GOTEBORG, Sweden; Recruiting

Research Site, LITTLE ROCK, Arkansas, United States; Recruiting

Research Site, HARTFORD, Connecticut, United States; Not yet recruiting

Research Site, PARK RIDGE, Illinois, United States; Not yet recruiting

Research Site, LOUISVILLE, Kentucky, United States; Recruiting

Research Site, DETROIT, Michigan, United States; Not yet recruiting

Research Site, SOUTHFIELD, Michigan, United States; Recruiting

research Site, New Brunswick, New Jersey, United States; Recruiting

Research Site, Buffalo, New York, United States; Recruiting

Research Site, CLEVELAND, Ohio, United States; Recruiting

Research Site, NORTH ADELAIDE, South Australia, Australia; Recruiting

Research Site, HOUSTON, Texas, United States; Not yet recruiting

Research Site, Fort Worth, Texas, United States; Not yet recruiting

Starting date: October 2007
Ending date: January 2010
Last updated: January 30, 2009