Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: Dexlansoprazole MR; Dexlansoprazole MR
Intervention description: Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.; Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Esophageal Reflux; Gastro-Esophageal Reflux; Gastroesophageal Reflux Disease; GERD; Regurgitation, Gastric; Heartburn; Drug Therapy; Adolescent

Summary:

      The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole
      modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with
      Symptomatic Gastroesophageal Reflux Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight is greater than or equal to 30 kg.

          -  Females of childbearing potential who are sexually active must agree to use an
             acceptable form of contraception, and can neither be pregnant nor lactating from
             Screening throughout the duration of the study.

          -  Must have an estimated creatinine clearance greater than or equal to 80 mL/minute as
             determined from the Cockcroft-Gault formula.

          -  Participants who take prescription or non-prescription proton pump inhibitors,
             histamine receptor antagonists (except cimetidine), sucralfate, or antacids on a
             regular or as required basis must agree to discontinue usage throughout the study.

          -  Must have a history of gastroesophageal reflux disease symptoms, as documented by a
             physician, for at least 2 months prior to Screening or is currently symptomatic.

          -  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, hepatic,
             hematopoietic, renal, or metabolic dysfunction, serious allergy, asthma, or allergic
             skin rash.

          -  Has any finding in his/her medical history, physical examination, or safety clinical
             laboratory tests giving reasonable suspicion of a disease that might interfere with
             the conduct of the trial or that would contraindicate taking dexlansoprazole MR or a
             similar drug in the same class.

          -  Has a known hypersensitivity to any proton pump inhibitors or any component of the
             formulation of dexlansoprazole MR (see most current version of the Investigator
             Brochures).

          -  Has a history of malignant disease.

          -  Has a positive test result for hepatitis B surface antigen, hepatitis C virus
             antibody.

          -  Has a known history of infection with the human immunodeficiency virus.

          -  Has donated or lost greater than or equal to 300 mL blood volume, undergone
             plasmapheresis, or has had a transfusion of any blood product within 90 days prior to
             the first dose of study drug.

          -  Is required to take or intends to continue taking any disallowed medication,
             prescription medication, herbal treatment or over-the counter medication that may
             interfere with evaluation of the study medication.

          -  Has consumed grapefruit or grapefruit juice within 14 days prior to the first dose of
             study drug or is unwilling to agree to abstain from grapefruit or grapefruit juice
             while participating in the study.

          -  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.

          -  Has participated in a study of an investigational agent (including dosing or follow
             up) within 30 days prior to first dose of study drug.

          -  Has an initial Screening Visit or Day -1 laboratory value that the principal
             investigator considers to be clinically significant.

          -  Participant is determined to be a CYP2C19 isozyme poor metabolizer (ie, genotyped
             homozygous non-wild type).

          -  Is unlikely to comply with the protocol or is unsuitable for any other reason per the
             opinion of the investigator