Clinical Trial: Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Lansoprazole Disposition in Young Children With Cystic Fibrosis
Brief Summary: The disposition of a number of drugs has been reported to be altered in patients with Cystic Fibrosis (CF). Changes in pharmacokinetic parameters observed included increased volumes of distribution and increased clearance of renally eliminated drugs. The purpose of this this study is to characterize the pharmacokinetics of IV lansoprazole and its metabolites in normal healthy children and children with Cystic Fibrosis (CF) ages 2 to < 10 years. It is suspected that children with CF will have a more rapid clearance as compared to healthy children.
Detailed Summary:
Cystic fibrosis (CF) impacts 1:2500 Caucasian newborns and results from a defect in the cystic fibrosis transmembrane conductance regulator chloride channel (CFTR) responsible for electrolyte regulation. Between 25 to 81% of the CF population have gastro-esophageal reflux disease (GERD), and proton pump inhibitors (PPIs) are frequently prescribed for this condition. Moreover, PPIs are commonly used in patients with CF to allow for better gastric acid stabilization so that pancreatic enzyme efficacy is optimized and nutritional status is improved. Lansoprazole is a PPI that is widely used for acid-related disorders including GERD.
The disposition of a number of drugs has been reported to be altered in CF. Changes in pharmacokinetic parameters observed in patients with CF include increased volumes of distribution and increased clearance of renally eliminated drugs. To date, the pharmacokinetics of PPIs in patients with CF have not been characterized.
This study is a pilot study to evaluate and compare the pharmacokinetics of a single dose of IV lansoprazole in CF and normal children 2 to < 10 years of age. A goal of 12 evaluable subjects ranging from 2 to < 10 years of age including both males and females with CF ∆F508 genotype will be recruited from CF clinic or inpatient. As a comparison group, six evaluable subjects who are normal, healthy children of similar demographic profile (age, gender, and race) will be recruited.
After informed consent/assent is obtained, screening procedures will be completed within 30 days of study participation. The pre-study screen includes an age-appropriate physical exam, medical history (current medication/herbal use), vital signs (non-crying sitting blood pressure and heart rate), height, weight, AST, ALT, and CBC. Subjects will
Sponsor: Arkansas Children's Hospital Research Institute
Current Primary Outcome: Examine the PK enantiomers of IV lansoprazole and metabolites, in normal children and children with CF.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To compare the differences in the PK enantiomers of IV lansoprazole and metabolites, between children with CF and normal healthy children
- Examine the PK enantiomers of IV lansoprazole and metabolites in relationship to CYP2C19 genotype in children with CF and normal healthy children
- To assess the effects of ontogeny on IV lansoprazole drug disposition
Original Secondary Outcome: Same as current
Information By: Arkansas Children's Hospital Research Institute
Dates:
Date Received: April 9, 2007
Date Started: June 2006
Date Completion:
Last Updated: January 10, 2011
Last Verified: January 2011
