{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,9,2]],"date-time":"2024-09-02T02:40:12Z","timestamp":1725244812610},"reference-count":32,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,8,7]],"date-time":"2024-08-07T00:00:00Z","timestamp":1722988800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The pharmacokinetics (PK) of naloxegol were characterized in pediatric subjects, aged 6\u00a0months or older to less than 18\u00a0years who either have or are at risk of developing opioid\u2010induced constipation following single dose administration. Subjects grouped as aged 12 years or older to less than 18\u00a0years, 6 months or older to less than 12\u00a0years, and 6\u00a0months or older to less than 6\u00a0years, received a single oral dose of naloxegol at doses that were estimated to achieve plasma exposures comparable to adult 12.5\u2010 or 25\u2010mg doses. Intensive and sparse plasma naloxegol samples were collected to assess naloxegol concentrations. Data were combined with previously collected adult PK data and used to estimate PK parameters using population PK analyses. Naloxegol PK was described using a 2\u2010compartment model with Weibull\u2010type absorption. Neither age nor body weight was identified as a significant covariate indicating similar PK properties in adult and pediatric subjects. PK estimates in the youngest age group were approximately 80% less than those in adults (12.5\u2010mg equivalent dose). Exposures in the other pediatric groups were similar to those in adult equivalent doses. The PK of naloxegol were characterized as linear over the dose range, with no clinically significant covariates and comparable PK characteristics in adults and pediatric subjects aged 6\u00a0months or older.<\/jats:p>","DOI":"10.1002\/cpdd.1457","type":"journal-article","created":{"date-parts":[[2024,8,7]],"date-time":"2024-08-07T14:11:53Z","timestamp":1723039913000},"page":"974-984","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Population Pharmacokinetics of Naloxegol in Pediatric Subjects Receiving Opioids"],"prefix":"10.1002","volume":"13","author":[{"given":"Matthew W.","family":"Hruska","sequence":"first","affiliation":[{"name":"Kyowa Kirin, Inc.  Princeton NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary Ann","family":"Mascelli","sequence":"additional","affiliation":[{"name":"Chinook Therapeutics Inc.  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