{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T16:39:32Z","timestamp":1781023172178,"version":"3.54.1"},"reference-count":18,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2018,9,19]],"date-time":"2018-09-19T00:00:00Z","timestamp":1537315200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010877","name":"ViiV Healthcare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010877","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2019,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Cabotegravir is an integrase inhibitor in clinical development for the treatment and prevention of HIV infection using oral tablets for short\u2010term, lead\u2010in use before subsequent administration of a long\u2010acting injectable formulation. This phase 1, single\u2010center, randomized, 2 \u00d7 2 crossover study evaluated the effect of a high\u2010fat meal on the pharmacokinetics (PK) of oral cabotegravir. Healthy adults received oral cabotegravir 30 mg as a single dose on 2 separate occasions, either after fasting or following a high\u2010fat meal (\u223c53% fat, \u223c870 kcal). Safety evaluations and serial PK samples were collected, and a mixed\u2010effects model was used to determine within\u2010participant treatment comparison of noncompartmental PK parameters. Twenty\u2010four patients were enrolled and had a mean body mass index of 25.6 kg\/m<jats:sup>2<\/jats:sup>; 67% were male. Compared with the fasting state, coadministration of cabotegravir with a high\u2010fat meal increased plasma cabotegravir area under the concentration\u2010time curve and maximal drug concentration, each by 14%. The slight 14% to 17% increase in exposure associated with a high\u2010fat, high\u2010calorie meal was not considered clinically significant. No grade 3\/4 adverse events (AEs), drug\u2010related AEs, or AEs leading to discontinuation were reported.<\/jats:p>","DOI":"10.1002\/cpdd.620","type":"journal-article","created":{"date-parts":[[2018,9,19]],"date-time":"2018-09-19T19:37:14Z","timestamp":1537385834000},"page":"443-448","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Effect of a High\u2010Fat Meal on the Pharmacokinetics of the HIV Integrase Inhibitor Cabotegravir"],"prefix":"10.1002","volume":"8","author":[{"given":"Parul","family":"Patel","sequence":"first","affiliation":[{"name":"ViiV Healthcare Research Triangle Park  NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan L.","family":"Ford","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Research Triangle Park  NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Lou","sequence":"additional","affiliation":[{"name":"PAREXEL International  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kalpana","family":"Bakshi","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Upper Providence PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allan R.","family":"Tenorio","sequence":"additional","affiliation":[{"name":"ViiV Healthcare Research Triangle Park  NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiping","family":"Zhang","sequence":"additional","affiliation":[{"name":"PAREXEL International  Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rennan","family":"Pan","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline  Upper Providence PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Spreen","sequence":"additional","affiliation":[{"name":"ViiV Healthcare Research Triangle Park  NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,9,19]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/COH.0000000000000002"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.7448\/IAS.17.4.19540"},{"key":"e_1_2_8_4_1","volume-title":"Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV","author":"Panel on Antiretroviral Guidelines for Adults and Adolescents","year":"2018"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.05739-11"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0000000000000469"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)31917-7"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(17)30068-1"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.3109\/00498254.2015.1081993"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.3109\/00498254.2015.1060372"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13236"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01235-13"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00487-17"},{"key":"e_1_2_8_14_1","article-title":"A phase I study to evaluate the pharmacokinetics and safety of cabotegravir in adults with severe renal impairment and healthy matched control participants","author":"Parasrampuria R","journal-title":"Clin Pharmacol Drug Dev"},{"key":"e_1_2_8_15_1","unstructured":"TherrienR.HIV\/HCV medication guide: antiretroviral chart. PublishedJune 2017.http:\/\/www.hivmedicationguide.com\/pdf\/chart-june-2017_en.pdfAccessed August 6 2018."},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270010367652"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.358"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-004-9004-4"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(15)00152-8"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcpdd.620","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.620","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.620","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.620","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T08:15:53Z","timestamp":1694333753000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.620"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,9,19]]},"references-count":18,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2019,5]]}},"alternative-id":["10.1002\/cpdd.620"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.620","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,9,19]]},"assertion":[{"value":"2018-02-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-08-16","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-09-19","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}