Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis

NCT00458614 | Completed Phase 1

• 1 other identifier: PPRU-10840
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Examine the PK enantiomers of IV lansoprazole and metabolites, in normal children and children with CF.

Secondary Outcomes (3)

• 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

Interventions

Lansoprazole DRUG

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital Little Rock

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Holly D Maples, Pharm.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: June 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

US (1)