Ramesh Boinpally, Matthew Butler, Jonathan Rojo, Lisa Borbridge, Veronica Wangsadipura, Anna Papinska
{"title":"联合剂与埃索美拉唑共给药的药代动力学相互作用和安全性评价。","authors":"Ramesh Boinpally, Matthew Butler, Jonathan Rojo, Lisa Borbridge, Veronica Wangsadipura, Anna Papinska","doi":"10.2217/pmt-2023-0040","DOIUrl":null,"url":null,"abstract":"<p><p><b>Aim:</b> To investigate potential pharmacokinetic interactions between atogepant and esomeprazole. <b>Methods:</b> Atogepant, esomeprazole, or both were administered to 32 healthy adults in an open-label, nonrandomized, crossover study. Systemic exposure (area under the plasma concentration-time curve [AUC] and peak plasma concentration [C<sub>max</sub>]) for atogepant administered in combination versus alone were compared using a linear mixed effects model. <b>Results:</b> Coadministration with esomeprazole delayed atogepant time to C<sub>max</sub> by ∼1.5 h and reduced C<sub>max</sub> by ∼23% with no statistically significant change in AUC compared with atogepant alone. Administration of atogepant 60 mg alone or in combination with esomeprazole 40 mg was well tolerated in healthy adults. <b>Conclusion:</b> Esomeprazole had no clinically meaningful effect on atogepant pharmacokinetics. <b>Clinical Trial Registration</b>: unregistered phase I study.</p>","PeriodicalId":20000,"journal":{"name":"Pain management","volume":"13 6","pages":"351-361"},"PeriodicalIF":1.4000,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evaluation of the pharmacokinetic interactions and safety of atogepant coadministered with esomeprazole.\",\"authors\":\"Ramesh Boinpally, Matthew Butler, Jonathan Rojo, Lisa Borbridge, Veronica Wangsadipura, Anna Papinska\",\"doi\":\"10.2217/pmt-2023-0040\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Aim:</b> To investigate potential pharmacokinetic interactions between atogepant and esomeprazole. <b>Methods:</b> Atogepant, esomeprazole, or both were administered to 32 healthy adults in an open-label, nonrandomized, crossover study. Systemic exposure (area under the plasma concentration-time curve [AUC] and peak plasma concentration [C<sub>max</sub>]) for atogepant administered in combination versus alone were compared using a linear mixed effects model. <b>Results:</b> Coadministration with esomeprazole delayed atogepant time to C<sub>max</sub> by ∼1.5 h and reduced C<sub>max</sub> by ∼23% with no statistically significant change in AUC compared with atogepant alone. Administration of atogepant 60 mg alone or in combination with esomeprazole 40 mg was well tolerated in healthy adults. <b>Conclusion:</b> Esomeprazole had no clinically meaningful effect on atogepant pharmacokinetics. <b>Clinical Trial Registration</b>: unregistered phase I study.</p>\",\"PeriodicalId\":20000,\"journal\":{\"name\":\"Pain management\",\"volume\":\"13 6\",\"pages\":\"351-361\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2023-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pain management\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2217/pmt-2023-0040\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain management","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2217/pmt-2023-0040","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Evaluation of the pharmacokinetic interactions and safety of atogepant coadministered with esomeprazole.
Aim: To investigate potential pharmacokinetic interactions between atogepant and esomeprazole. Methods: Atogepant, esomeprazole, or both were administered to 32 healthy adults in an open-label, nonrandomized, crossover study. Systemic exposure (area under the plasma concentration-time curve [AUC] and peak plasma concentration [Cmax]) for atogepant administered in combination versus alone were compared using a linear mixed effects model. Results: Coadministration with esomeprazole delayed atogepant time to Cmax by ∼1.5 h and reduced Cmax by ∼23% with no statistically significant change in AUC compared with atogepant alone. Administration of atogepant 60 mg alone or in combination with esomeprazole 40 mg was well tolerated in healthy adults. Conclusion: Esomeprazole had no clinically meaningful effect on atogepant pharmacokinetics. Clinical Trial Registration: unregistered phase I study.