Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Modified Release Capsules (30 mg and 60 mg) in Adolescents With Symptomatic Gastroesophageal Reflux Disease|
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter [ Time Frame: After 7 days of dosing. ]Tmax: Time to reach the Maximum Plasma Concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 7.
- Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ]Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
- AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ]Area Under the Plasma Concentration Versus Time Curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
- AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ]AUC(0-24) is measure of Area Under the Curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 24 hours in this study).
- Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ]Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
- Oral Clearance (CL/F) Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ]CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.
- Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ]Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.
- Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter. [ Time Frame: After 7 days of dosing. ]Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.
|Study Start Date:||May 2009|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
|Experimental: Dexlansoprazole MR 30 mg QD||
Drug: Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
|Experimental: Dexlansoprazole MR 60 mg QD||
Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
Gastroesophageal reflux disease is a condition of multifactorial etiology resulting in the reflux of gastric contents into the esophagus through the lower esophageal sphincter. The prevalence of Gastroesophageal reflux disease in the pediatric population is becoming increasingly recognized and documented. It is a chronic disease that can persist through adulthood with symptoms in older children and adolescents being similar to those seen in adults. The prevalence of gastroesophageal reflux disease increases with age, from 2.5% of children between the ages of 3 and 9 years, to 8.5% of those between the ages of 10 and 17 years.
Younger children generally present with extra-esophageal manifestations, regurgitation, and epigastric pain, while older children and adolescents typically present with adult-type gastroesophageal reflux disease symptoms of heartburn and regurgitation. Treatment for gastroesophageal reflux disease is aimed at alleviating symptoms and healing the esophageal inflammation.
This study evaluated the pharmacokinetics and safety of dexlansoprazole MR in the pediatric population (ages 12-17) and determined if the pharmacokinetic profile is similar to that in adults given the same dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847210
|United States, California|
|Anaheim, California, United States|
|Cypress, California, United States|
|United States, Kansas|
|Overland Park, Kansas, United States|
|Study Director:||Medical Director Pharmacovigilance||Takeda|