Pharmacokinetics and Safety of Dexlansoprazole MR in Adolescents With Symptomatic GERD

Abstract

Dexlansoprazole MR 30 mg once daily (QD) is approved in adults for the treatment of symptomatic nonerosive gastroesophageal reflux disease (GERD) and maintenance of healed erosive esophagitis (EE); 60 mg is approved for healing EE. The present study assesses the pharmacokinetic (PK) profile and safety of dexlansoprazole MR in adolescent patients. Phase 1, open-label, parallel-group, multicenter study in male and female adolescents (12-17 years) with GERD. Patients were randomized to receive dexlansoprazole MR (30 or 60 mg, QD) for 7 days. Blood samples to determine dexlansoprazole plasma concentrations were drawn over a 24-hour period after dosing on day 7. Dexlansoprazole plasma concentrations and PK parameters were summarized by dose group. Safety assessments included monitoring of adverse events (AEs). Thirty-six patients (mean age 14.6 years), 14 boys and 22 girls, were randomized, with PK data available for 35 patients. The overall exposure of dexlansoprazole after administration of the 60-mg capsule was slightly less than double the exposure from the 30-mg capsule. Cmax (691 and 1136 ng/mL) and area under the plasma concentration time curve (2886 and 5120 ng · h/mL) values for the 30- and 60-mg doses, respectively, were similar to results from previous phase 1 studies in healthy adults. Twelve of 36 patients (33.3%) experienced a total of 21 treatment-emergent AEs. All of the AEs were considered to be of mild severity. The PK data for dexlansoprazole MR 30- and 60-mg capsules in adolescent patients with symptomatic GERD were similar to those in healthy adults. Both doses were well tolerated.