A Pharmacokinetics (Blood Levels), Pharmacodynamics (How the Drug Acts on the Body) and Safety Study Dosing of Rabeprazole in New Borns With Gastroesophageal Reflux Disease (GERD).

Condition(s) targeted: Gastroesophageal Reflux

Intervention: Rabeprazole sodium (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall contact:
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com

The purpose of this study is to evaluate the pharmacokinetics (blood levels), pharmacodynamics (how the drug acts on the body), and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in new borns and pre-term infants (less than 44 weeks of age).

Official title: A Pharmacokinetic, Pharmacodynamic and Short-term Safety Study of Single and Multiple Day Doses of Rabeprazole Sodium in Neonates and Pre-term Infants With a Corrected Age of Less Than 44 Weeks With a Presumptive Diagnosis of GERD

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study

Primary outcome: To evaluate the pharmacokinetics (PK) using population PK methods, pharmacodynamics and safety of rabeprazole for the treatment of GERD in new born patients.This study is necessary to identify an effective dose

Detailed description: This is an multi-center Phase I study in new borns and pre-term infants (less than 44 weeks at the time of the first dose). The drug being studied is rabeprazole sodium, the active pharmaceutical ingredient in AcipHex. This study will consist of two parts, Part 1 and Part 2. Each part will consist of three phases, a pre-treatment phase (screening of up to 7 days before the start of treatment), a treatment phase (up to 28 days) and a post treatment phase (at least 14 days, but no more than 21 days after the last dose of study drug). The maximum study length for each patient will therefore be up to 8 weeks. Patients will be monitored patients with a presumptive diagnosis of GERD and who need a feeding tube for enteral alimentation (complete or partial) in place and have been admitted to a newborn intensive care unit or step down unit. The population blood level (pharmacokinetics) results, together with the safety and tolerability data, from Part 1 will be assessed to determine the two dose levels to be studied in Part 2 before the start of dosing. All 14 patients in Part 1 will require pH monitoring for clinical management and undergo a 24-hour PD assessment (intraesophageal and intragastric pHmetry). At least 6 patients in Part 2 (3 patients from each dose group) will require pH monitoring and undergo the same pharmacodynamics assessment as patients in Part 1. Patients participating in the pHmetry assessment must be in need of this assessment for their clinical management in the opinion of the Principal Investigator. The intraesophageal and intragastric 24-hour pH

pharmacodynamics assessment in both Part 1 and Part 2 will be performed at baseline (Day - 1)

and after the first dose (Day 1) and fifth dose (Day 5). Sampling for single dose blood level (Pharmacokinetic) evaluations will be performed post-dose on Day 1. Sampling blood level evaluations at the presumed steady-state during multiple dosing will be performed on Day 5. Patients' safety will be monitored throughout the study. At the end of the study, or if any patient prematurely discontinues his/her participation in the study, a safety evaluation will be performed at least 14 days, but no more than 21 days, after the final rabeprazole sodium dose. During the course of the study, after consent each patient will have medical history, a physical, length, weight, vital signs, blood chemistry, and urinanalysis. Safety from baseline to the End of Study visit (post-treatment phase) will be evaluated by examining incidence, severity and relationship to the study drug and type of Adverse Events (AEs), urinalysis, physical examination and vital signs. Patients will receive rabeprazole sodium as a single daily dose for up to 28 consecutive days. Patients participating in Part 1 will receive 1. 0 mg rabeprazole sodium administered by a nasogastric tube. After four patients complete Part 1, their rabeprazole plasma levels will be assess and may be increased to 2. 0 mg rabeprazole sodium. The population pharmacokinetics results, safety and tolerability data from Part 1 will be assessed to determine 2 doses in Part 2.

Minimum age: N/A. Maximum age: 44 Weeks. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must need a feeding tube in place for enteral alimentation (complete or

partial) and be in a neonatal intensive care unit or step down unit

- Patients participating in the pHmetry assessment must be in need of this assessment

- New born, neonate or pre-term infants less than 44 weeks with a minimum weight of 0. 8

kg and with a presumptive diagnosis of GERD

- Patients who have been treated with, or are currently receiving a PPI, H2-blockers or

antacids

- Patients should be generally healthy, other than for the presence of GERD.

Exclusion Criteria:

- A history of or current clinically significant medical illness (excluding GERD,

asthma, reactive airway disease or cystic fibrosis-dependant GERD)

- Serum concentrations of hepatic transaminases > 3-fold higher than the upper limit of

normal for age creatinine values = 106 mmol/L.

- Clinically relevant abnormal laboratory values

This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com

Ending date: April 2010
Last updated: August 27, 2009