Pharmacokinetics and safety of dexlansoprazole MR in adolescents with symptomatic GERD

Abstract

Objectives: 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.

Patients and methods: 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).

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT00847210.