{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T00:03:54Z","timestamp":1784851434850,"version":"3.55.0"},"reference-count":4,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2020,6,18]],"date-time":"2020-06-18T00:00:00Z","timestamp":1592438400000},"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":[[2020,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>GSK2838232 is a novel, potent HIV\u20101 maturation inhibitor for use in regimen\u2010based combination antiretroviral therapy from a once\u2010daily oral dose boosted with a pharmacoenhancer (ritonavir or cobicistat). This phase 1 study in healthy participants was conducted in 2 parts. Part 1 (n = 14) assessed the relative bioavailability of single doses of a 200\u2010mg GSK2838232 tablet and capsule formulation boosted with 100\u00a0mg ritonavir in fed and fasted (tablet\u2010only) subjects. Part\u00a02 (n = 10) assessed the pharmacokinetics of repeated 500\u2010mg once\u2010daily doses of GSK2838232 without a pharmacoenhancing boosting agent. In part 1, GSK2838232 demonstrated comparable bioavailability following a single dose of 200\u00a0mg GSK2838232 as capsule and tablet formulations in combination with ritonavir (RTV) under fed conditions, with lower intrasubject variability observed for the tablet formulation. In part 2, following administration of 500\u00a0mg GSK2838232 once daily for 11 days under fed conditions, C<jats:sub>max<\/jats:sub>, AUC<jats:sub>0\u2010\u03c4<\/jats:sub>, and C\u03c4 showed a small degree of accumulation (1.2\u2010 to 1.3\u2010fold) of GSK2838232. The median t<jats:sub>max<\/jats:sub> was approximately 4\u00a0hours on both day 1 and day\u00a011 when given with food. The mean t<jats:sub>\u00bd<\/jats:sub> was approximately 23\u00a0hours on day 11. Steady\u2010state concentrations were achieved by day\u00a03 with a geometric mean steady\u2010state C\u03c4 on day 11 of 28\u00a0ng\/mL. The tablet formulation was generally well tolerated as a single 200\u2010mg dose with RTV under fed and fasted conditions and following administration of multiple daily doses (11\u00a0days) of 500\u00a0mg unboosted.<\/jats:p>","DOI":"10.1002\/cpdd.820","type":"journal-article","created":{"date-parts":[[2020,6,19]],"date-time":"2020-06-19T06:48:18Z","timestamp":1592549298000},"page":"972-977","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["A Phase 1 Study to Assess the Relative Bioavailability, Food Effect, and Safety of a Tablet Formulation of GSK2838232, a Novel HIV Maturation Inhibitor in Healthy Participants After Single and Repeated Doses"],"prefix":"10.1002","volume":"9","author":[{"given":"Mark","family":"Johnson","sequence":"first","affiliation":[{"name":"Clinical Pharmacology GlaxoSmithKline  Research Triangle Park North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roxanne C.","family":"Jewell","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Modeling and Simulation GlaxoSmithKline  Research Triangle Park North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianjun","family":"Gan","sequence":"additional","affiliation":[{"name":"Biostatistics GlaxoSmithKline  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Etienne","family":"Dumont","sequence":"additional","affiliation":[{"name":"Clinical Development GlaxoSmithKline  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Burns","sequence":"additional","affiliation":[{"name":"Global Clinical Sciences &amp; Delivery GlaxoSmithKline  Abbotsford Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian A.","family":"Johns","sequence":"additional","affiliation":[{"name":"HIV Discovery Performance Unit GlaxoSmithKline  Research Triangle Park North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,6,18]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"United Nations program on HIV\/AIDS (UNAIDS) Fact Sheet 2015.www.UNAIDS.org. Accessed June 2018."},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/med.20138"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/prp2.408"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz938"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcpdd.820","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.820","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.820","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.820","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,28]],"date-time":"2023-08-28T15:54:52Z","timestamp":1693238092000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.820"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,6,18]]},"references-count":4,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2020,11]]}},"alternative-id":["10.1002\/cpdd.820"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.820","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,6,18]]},"assertion":[{"value":"2019-11-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-05-04","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-06-18","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}