{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T02:44:19Z","timestamp":1792118659526,"version":"4.4.0"},"reference-count":9,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2019,1,1]],"date-time":"2019-01-01T00:00:00Z","timestamp":1546300800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Alkermes, Inc."}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Psychopharmacology"],"published-print":{"date-parts":[[2019,1]]},"abstract":"\n Background:<\/jats:title>\n \n Aripiprazole lauroxil (AL), a long-acting injectable antipsychotic for the treatment of schizophrenia in adults, can be started with either 21\u2009days of daily oral aripiprazole supplementation or a 1-day initiation regimen consisting of a single injection of a NanoCrystal\n \u00ae<\/jats:sup>\n Dispersion formulation of AL (AL\n NCD<\/jats:sub>\n ) and a single dose of 30\u2009mg oral aripiprazole. This phase I study assessed the pharmacokinetics and safety of deltoid versus gluteal AL\n NCD<\/jats:sub>\n injections.\n <\/jats:p>\n <\/jats:sec>\n \n Methods:<\/jats:title>\n \n Patients with schizophrenia or schizoaffective disorder ( N\u2009=\u200947) were randomized 1:1 to receive a single intramuscular dose of AL\n NCD<\/jats:sub>\n in the deltoid or gluteal muscle. Plasma samples were collected over 85\u2009days to measure AL\n NCD<\/jats:sub>\n concentration by injection site. Relative aripiprazole bioavailability for deltoid versus gluteal injection was assessed based on area under the curve (AUC\n \u221e<\/jats:sub>\n and AUC\n last<\/jats:sub>\n ) and maximum concentration (C\n max<\/jats:sub>\n ) values. Adverse events were monitored throughout the study.\n <\/jats:p>\n <\/jats:sec>\n \n Results:<\/jats:title>\n \n Plasma aripiprazole concentrations after a single AL\n NCD<\/jats:sub>\n injection were comparable between deltoid and gluteal administration. Mean maximum plasma aripiprazole concentrations were 196.1\u2009ng\/ml (deltoid) and 175.0\u2009ng\/ml (gluteal). Exposure to aripiprazole was similar, with mean AUC\n \u221e<\/jats:sub>\n values of 6591\u2009day\u2009\u00d7\u2009ng\/ml for deltoid and 6437\u2009day\u2009\u00d7\u2009ng\/ml for gluteal. Aripiprazole bioavailability was not significantly different between injection sites. AL\n NCD<\/jats:sub>\n administration in the deltoid or gluteal muscle was well tolerated, with similar safety profiles at both sites.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion:<\/jats:title>\n \n AL\n NCD<\/jats:sub>\n demonstrated similar exposure and safety profiles between the two administration sites, suggesting that AL\n NCD<\/jats:sub>\n can be given in either the gluteal or the deltoid muscles as a component of the 1-day initiation regimen for AL.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1177\/2045125319859964","type":"journal-article","created":{"date-parts":[[2019,7,2]],"date-time":"2019-07-02T03:14:21Z","timestamp":1562037261000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":18,"title":["Pharmacokinetics and safety of deltoid or gluteal injection of aripiprazole lauroxil NanoCrystal\n \u00ae<\/sup>\n Dispersion used for initiation of the long-acting antipsychotic aripiprazole lauroxil"],"prefix":"10.1177","volume":"9","author":[{"given":"Marjie L.","family":"Hard","sequence":"first","affiliation":[{"name":"Alkermes, Inc., Waltham, MA, USA"},{"name":"Moderna Therapeutics, Cambridge, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Wehr","sequence":"additional","affiliation":[{"name":"Alkermes, Inc., Waltham, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"von Moltke","sequence":"additional","affiliation":[{"name":"Alkermes, Inc., Waltham, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yangchun","family":"Du","sequence":"additional","affiliation":[{"name":"Alkermes, Inc., Waltham, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Farwick","sequence":"additional","affiliation":[{"name":"Uptown Research Institute, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8638-2086","authenticated-orcid":false,"given":"David P.","family":"Walling","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Sonnenberg","sequence":"additional","affiliation":[{"name":"Uptown Research Institute, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2019,7,2]]},"reference":[{"key":"bibr1-2045125319859964","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0000000000000921"},{"key":"bibr2-2045125319859964","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2014.09.021"},{"key":"bibr3-2045125319859964","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.14m09741"},{"key":"bibr4-2045125319859964","unstructured":"Aristada [package insert]. Waltham, MA: Alkermes, Inc. 2018."},{"key":"bibr5-2045125319859964","doi-asserted-by":"publisher","DOI":"10.1016\/S0928-0987(02)00251-8"},{"key":"bibr6-2045125319859964","doi-asserted-by":"publisher","DOI":"10.1007\/s13318-018-0488-4"},{"key":"bibr7-2045125319859964","doi-asserted-by":"publisher","DOI":"10.1016\/j.pnpbp.2009.05.014"},{"key":"bibr8-2045125319859964","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0000000000000691"},{"key":"bibr9-2045125319859964","doi-asserted-by":"publisher","DOI":"10.1186\/1471-244X-13-58"}],"container-title":["Therapeutic Advances in Psychopharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2045125319859964","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/2045125319859964","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/2045125319859964","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T23:51:37Z","timestamp":1777593097000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/2045125319859964"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,1]]},"references-count":9,"alternative-id":["10.1177\/2045125319859964"],"URL":"https:\/\/doi.org\/10.1177\/2045125319859964","relation":{},"ISSN":["2045-1253","2045-1261"],"issn-type":[{"value":"2045-1253","type":"print"},{"value":"2045-1261","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,1]]},"article-number":"2045125319859964"}}