title: Pharmacokinetics and safety of dexlansoprazole MR in adolescents with symptomatic GERD.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Takeda Global Research & Development Center, Inc, Deerfield, IL 60015, USA. michael.kukulka@tgrd.com
authors.forename: Michael
authors.initials: M
authors.lastname: Kukulka
authors.forename: Jingtao
authors.initials: J
authors.lastname: Wu
authors.forename: Maria Claudia
authors.initials: MC
authors.lastname: Perez
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use; D000293:Adolescent; D019540:Area Under Curve; D002648:Child; D064748:Dexlansoprazole; D004941:Esophagitis / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000627:therapeutic use
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D064748:Dexlansoprazole