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This model\u2010based pharmacokinetic (PK)\u2010pharmacodynamic (PD) analysis quantified the impact of age and alcohol use on pupillometry and cold pressor test (CPT) PD based on data from an open\u2010label study of a single, immediate\u2010release 10\u2010mg oral oxycodone in middle\u2010age and older adults (aged 35\u201085) without severe functional limitations. PK and pupillometry assessments were obtained on 11 occasions over 8 hours. Cold pressor test was administered at 1.5, 5, and 8 hours after oxycodone dosing. The study population consisted of 62 older adults (aged \u226560) and 66 middle\u2010aged adults (aged 35\u201059), with 82% meeting the unhealthy drinking criteria. Oral oxycodone PK were well described using a 1\u2010compartment model with a sequential 0 to first\u2010order absorption process. Inhibitory maximum effect and linear direct effect PD models described the respective pupillometry and cold pressor test data using simultaneous PK\u2010PD analysis in MONOLIX. Recent alcohol use measures were selected a priori as covariates. This analysis demonstrated an influence of age on clearance and body weight on the distribution volume of oxycodone; alcohol consumption was not noted to alter oxycodone PK. Oxycodone pupillometry PD were influenced by the level of subject\u2010reported alcohol consumption (Alcohol Use Disorders Identification Test for Consumption), alcohol use biomarker\u2013blood phosphatidylethanol, previous cannabis use, and age. Over the opioid exposure range of the study, none of the covariables including alcohol and age were noted to affect cold pressor test pharmacodynamics. Additional clinical studies are needed to further investigate the clinical consequences of opioid\u2010alcohol\u2010age interaction.<\/jats:p>","DOI":"10.1002\/jcph.2058","type":"journal-article","created":{"date-parts":[[2022,4,8]],"date-time":"2022-04-08T12:40:22Z","timestamp":1649421622000},"page":"1177-1190","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Model\u2010Based Analysis of the Influence of Alcohol Use and Age on Pharmacokinetics\u2010Pharmacodynamics of Oral Oxycodone in Middle\u2010Age and Older Community\u2010Dwelling Adults"],"prefix":"10.1002","volume":"62","author":[{"given":"Bojan B.","family":"Lalovic","sequence":"first","affiliation":[{"name":"Clinical Pharmacology Sciences Modeling and Simulation Medicines Development Center Eisai Inc.  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