Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Dexlansoprazole; Dexlansoprazole; Dexlansoprazole
Intervention description: Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.; Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days; Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 1 Year
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Gastroesophageal Reflux; Erosive Esophagitis; Pharmacokinetics; Pediatrics; Drug Therapy

Summary:

      The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole,
      once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a body weight within the 5th through 95th percentile by age, inclusive, as
             determined by the National Center for Health Statistics .

          -  Females of childbearing potential must not be nursing, must have a negative serum
             pregnancy test at the Screening Visit and on Day -1, and if sexually active agree to
             routinely use adequate contraception from Screening and throughout the duration of the
             study.

          -  Subjects who take prescription or non-prescription proton pump inhibitors (PPI),
             histamine receptor antagonists (except cimetidine), sucralfate, or antacids on a
             regular or as required basis must agree to discontinue usage on Day -1 and agree to
             discontinue use throughout the study.

          -  Must have a history of GERD symptoms for at least 2 months prior to Screening or is
             currently symptomatic, as determined by the investigator.

          -  Must be able to swallow study drug capsule or must be able to ingest study drug
             granules sprinkled on 1 tablespoon of applesauce.

        Exclusion Criteria:

          -  Has evidence of current cardiovascular, central nervous system, pulmonary, endocrine
             disease, hepatic, hematopoietic, renal, or metabolic dysfunction, serious allergy,
             asthma, or allergic skin rash.

          -  Has a known hypersensitivity to any PPI or any component of the formulation of
             dexlansoprazole capsules.

          -  Is taking any other prescription (except birth control) or nonprescription medication
             (including cimetidine), vitamins, or dietary supplements within 10 days prior to Day
             1, or has taken herbal over-the-counter medications within 28 days prior to Day 1.

          -  Has a positive test result for hepatitis B surface antigen or hepatitis C virus
             antibody.

          -  Has donated or lost greater than 10% of the total blood volume, undergone
             plasmapheresis, or has had a transfusion of any blood product within 90 days prior to
             the first dose of study drug.

          -  Has a history of alcohol abuse or illegal drug use or drug abuse in the past, or tests
             positive for alcohol or drugs of abuse at the initial Screening Visit or Day -1 or is
             unwilling to agree to abstain from alcohol and drugs throughout the study.

          -  Has used a product containing nicotine within 90 days prior to the first dose of study
             drug or has a positive cotinine screen at the initial Screening Visit or Day -1 or is
             unwilling to agree to abstain throughout the study.

          -  Is determined to be a Cytochrome P450 2C19 poor metabolizer (ie, genotyped homozygous
             non-wild-type).