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.
Gastroesophageal Reflux Disease (GERD) is a condition of several causes resulting in the backward flow of gastric contents into the esophagus through the lower esophageal sphincter. The prevalence of GERD in the pediatric population is increasingly becoming recognized and documented. It is a disease that may persist through adulthood, with symptoms in older children and adolescents similar to those seen in adults. Younger children generally present with extra-esophageal manifestations, regurgitation, and epigastric pain, while older children and adolescents typically present with adult-type GERD symptoms of heartburn and regurgitation. Treatment for GERD is aimed at improving symptoms and healing esophageal inflammation. Takeda Global Research \& Development Center, Inc. (TGRD) developed dexlansoprazole delayed release capsules as a new therapy for treating acid related disorders including symptomatic non-erosive GERD, healing of erosive esophagitis (EE) and maintenance of healed EE. Dexlansoprazole delayed release capsules have not been studied in subjects younger than 12 years of age. This study is designed to evaluate the safety of dexlansoprazole delayed release capsules in the pediatric population (1 to 11 years old) and to determine if the PK profile of dexlansoprazole in subjects 1 to 11 years of age is similar to that in adults given a similar dose. Subjects who satisfy the screening evaluation and Inclusion/Exclusion Criteria may be enrolled in the study. Eligible subjects will be assigned to one of three treatment groups. Attempts will be made to enroll an equal number of male and female subjects in each treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
36
Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Unnamed facility
Anaheim, California, United States
Unnamed facility
Miami Garden, Florida, United States
Unnamed facility
Kansas City, Missouri, United States
Unnamed facility
Cincinnati, Ohio, United States
Time to Reach the Peak Plasma Concentration (Tmax)
Time to reach the maximum plasma concentration (Cmax) of Dexlansoprazole, equal to time (hours) to Cmax, as observed on Day 7. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.
Time frame: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.
The Peak Plasma Concentration (Cmax)
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.
Time frame: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc))
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.
Time frame: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24))
AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole.
Time frame: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.
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