Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease

Completed · Phase 1

Conditions studied: Gastroesophageal Reflux

In brief

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.

Key facts

Study ID

NCT01045096

Run by

Takeda

People needed

36

Starts

2010-03-01

Expected to finish

2011-02-01

Last updated by the study team

2012-04-05

Who can join

Age: 1 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Study site — Anaheim, California, United States
• Study site — Miami Garden, Florida, United States
• Study site — Kansas City, Missouri, United States
• Study site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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