Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arkansas Children's Hospital Research Institute
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

• Subjects who have the diagnosis of CF with the ∆F508 genotype (hetero- or homozygous) or who are normal and healthy as determined by the principal investigator, have in the past year received a H2 receptor antagonist, PPI, or antacid, and do not meet any of the exclusion criteria.

• Subjects of either gender and all races and ethnicity age 2 to < 10 years.

• Written informed consent from parent or guardian who has sufficient intellectual capacity to understand the study and adhere to the procedures and as applicable (i.e., subjects ≥ 7 years of age), subject assent.

Exclusion Criteria:

• Refusal of informed consent/assent by the parent/caregiver and child > 7 years of age.

• Body weight less than 10 kg.

• Three or more hospitalizations during the preceding year.

• Severe liver dysfunction (AST & ALT > 3 times the upper normal limit).

• Clinically significant (determined by investigator) alterations in hemoglobin and/or hematocrit.

• Pregnancy or lactation.

• Concurrent therapy with agents other than a PPI that are known to be CYP2C19 substrates within 2 weeks of study drug administration

• PPI use within 48 hours of study drug administration.

• Acute change in health status within 72 hours of study drug administration.

• Allergy or hypersensitivity to lansoprazole or to other proton pump inhibitors