{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T14:05:15Z","timestamp":1781013915413,"version":"3.54.1"},"reference-count":34,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T00:00:00Z","timestamp":1768780800000},"content-version":"vor","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100015217","name":"Veloxis Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015217","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":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Grapefruit juice (GFJ) is a known inhibitor of intestinal cytochrome P450 3A (CYP3A) metabolism leading to increased exposure to CYP3A substrates such as tacrolimus. The extended\u2010release tacrolimus formulation Envarsus (LCPT) exhibits prolonged absorption throughout the entire GI tract. Although a clinically significant drug\u2013drug interaction occurs with immediate\u2010release tacrolimus formulations, this has not been evaluated with extended\u2010release formulations. This study assessed the impact of GFJ on LCPT in adult kidney transplant patients. Eleven adult kidney transplant recipients on a stable dose of LCPT were enrolled in a randomized crossover study. Participants were administered either GFJ or water during each pharmacokinetic visit, with midazolam used as a positive control. A washout period of 2\u20134 weeks was included between visits. Tacrolimus concentrations were determined using validated LC\u2010MS\/MS methods. Tacrolimus AUC\n                    <jats:sub>0\u201324<\/jats:sub>\n                    was 28% higher with GFJ (GMR = 1.28, 90% CI 1.12\u20131.44) and C\n                    <jats:sub>max<\/jats:sub>\n                    was 73% higher (GMR = 1.73, 90% CI 1.46\u20132.00) compared to control. GFJ exhibited a clinically meaningful interaction with LCPT. However, the magnitude appears less than those reported with immediate\u2010release formulations, suggesting the extended absorption profile of LCPT may affect susceptibility to drug interactions in the intestine.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70016","type":"journal-article","created":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T08:47:58Z","timestamp":1768812478000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Assessment of the Intestinal CYP3A Contribution to Drug Interactions with Extended\u2010Release Tacrolimus (LCPT) Using Grapefruit Juice"],"prefix":"10.1002","volume":"15","author":[{"given":"Adekunle","family":"Alabi","sequence":"first","affiliation":[{"name":"Department of Pathology University of Colorado Anschutz Medical Campus  Aurora CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janice S.","family":"Kerr","sequence":"additional","affiliation":[{"name":"Department of Pharmacy UC San Diego Health San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mita","family":"Shah","sequence":"additional","affiliation":[{"name":"Department of Medicine UC San Diego Health  San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adnan","family":"Khan","sequence":"additional","affiliation":[{"name":"Department of Medicine UC San Diego Health  San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph D.","family":"Ma","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences, UC San Diego  La Jolla CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raymond T.","family":"Suhandynata","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and Pharmaceutical Sciences, UC San Diego  La Jolla CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremiah D.","family":"Momper","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and \u00a0Pharmaceutical Sciences, UC San Diego  La Jolla CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shirley M.","family":"Tsunoda","sequence":"additional","affiliation":[{"name":"Skaggs School of Pharmacy and \u00a0Pharmaceutical Sciences, UC San Diego  La Jolla CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,1,19]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.3389\/frtra.2023.1160752"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/43.11.2189"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics14102154"},{"issue":"3","key":"e_1_2_10_5_1","first-page":"391","article-title":"The effect of cytochrome P450 metabolism on drug response, interactions, and adverse effects","volume":"76","author":"Lynch T","year":"2007","journal-title":"Am Fam Physician"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.2174\/138920008786049276"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.1998.00764.x"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.120951"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-009-0702-z"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1248\/bpb.26.1371"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/0009-9236(95)90032-2"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.2133\/dmpk.21.122"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1155\/2011\/751671"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1177\/00912700122009999"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270003261078"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.transproceed.2016.02.002"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1586\/1744666X.2014.983903"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6904-5-4"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.967"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1529"},{"issue":"1","key":"e_1_2_10_21_1","first-page":"36","article-title":"Measurement of whole blood tacrolimus concentrations by LC\u2010MS\/MS and immunoassay methods: influence of immediate\u2010release vs extended\u2010release tacrolimus formulations","volume":"10","author":"Alabi A","year":"2025","journal-title":"J Appl Lab Med"},{"key":"e_1_2_10_22_1","unstructured":"U.S. Food and Drug Administration.M12 Drug Interaction Studies. Accessed April 16 2025.https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/m12\u2010drug\u2010interaction\u2010studies."},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.clpt.6100452"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12785"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.1364"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1006\/abbi.2000.1835"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0090-9556(25)08464-8"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clpt.2004.02.007"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-016-3060-4"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1097\/FPC.0b013e328307c26e"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1097\/FPC.0b013e32832bd085"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.112.049940"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.1989.tb03428.x"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3565(25)22834-8"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajt.2025.07.1858"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70016","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70016","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70016","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,24]],"date-time":"2026-01-24T14:23:08Z","timestamp":1769264588000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70016"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1]]},"references-count":34,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1]]}},"alternative-id":["10.1002\/cpdd.70016"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70016","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1]]},"assertion":[{"value":"2025-11-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-17","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70016"}}