{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T21:55:28Z","timestamp":1770069328756,"version":"3.49.0"},"reference-count":15,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2023,11,1]],"date-time":"2023-11-01T00:00:00Z","timestamp":1698796800000},"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":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Saroglitazar magnesium, a dual peroxisome proliferator\u2013activated receptor agonist, is under evaluation for treating various liver conditions. While the pharmacokinetics (PK) of saroglitazar have been extensively studied in diverse preclinical models and healthy subjects, a comprehensive assessment of its PK behavior under conditions of hepatic impairment is lacking. In this Phase 1, open\u2010label, parallel\u2010group study, the PK of a single dose of 4\u2010mg saroglitazar magnesium was investigated in subjects having varying degrees of hepatic impairment with and without portal hypertension compared with appropriately matched individuals having normal hepatic function. Treatment\u2010emergent adverse events for safety were also evaluated. Thirty\u2010two subjects were enrolled in the hepatic\u2010impaired groups and 23 subjects in the normal hepatic function group. Mild and moderate hepatic impairment did not significantly affect the PK of saroglitazar, compared with normal hepatic function. Although severe hepatic impairment did not alter maximum observed plasma concentration and half\u2010life; saroglitazar exposure (area under the plasma concentration\u2013time curve from time 0 to infinity) increased 3\u2010fold, while the clearance was 61% lower compared to the subjects with normal hepatic function. This may require close monitoring or dose adjustments in individuals with severe hepatic impairment. A single oral dose of saroglitazar magnesium 4\u00a0mg was found to be safe and well tolerated in subjects with varying degrees of hepatic function.<\/jats:p>","DOI":"10.1002\/cpdd.1339","type":"journal-article","created":{"date-parts":[[2023,11,1]],"date-time":"2023-11-01T08:04:11Z","timestamp":1698825851000},"page":"1142-1155","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Pharmacokinetics and Safety Evaluation of Single\u2010Dose Saroglitazar Magnesium in Subjects with Hepatic Impairment"],"prefix":"10.1002","volume":"12","author":[{"given":"Eric","family":"Lawitz","sequence":"first","affiliation":[{"name":"Clinical Professor of Medicine University of Texas Health Science Center  San Antonio TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deven","family":"Parmar","sequence":"additional","affiliation":[{"name":"Zydus Therapeutics Inc. Clinical Research and Development  Pennington NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Taufik","family":"Momin","sequence":"additional","affiliation":[{"name":"Zydus Lifesciences Ltd.  Ahmedabad Gujarat India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Farheen","family":"Shaikh","sequence":"additional","affiliation":[{"name":"Zydus Therapeutics Inc. Clinical Research and Development  Pennington NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harilal","family":"Patel","sequence":"additional","affiliation":[{"name":"Zydus Lifesciences Ltd.  Ahmedabad Gujarat India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helen","family":"Hayes","sequence":"additional","affiliation":[{"name":"Zydus Therapeutics Inc. Clinical Research and Development  Pennington NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimberly","family":"Swint","sequence":"additional","affiliation":[{"name":"Zydus Therapeutics Inc. Clinical Research and Development  Pennington NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,11]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.27368"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2014.07.056"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.26672"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cld.2011.03.007"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2011.10.027"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.31843"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2021.08.025"},{"key":"e_1_2_7_9_1","first-page":"10","article-title":"Saroglitazar improves nonalcoholic fatty liver disease and metabolic health in liver transplant recipients","author":"Siddiqui MS","year":"2023","journal-title":"Liver Transplant"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-013-0128-3"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1080\/00498254.2017.1413264"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/1932296813518680"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2013.0253"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-017-0584-2"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1008656930082"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(19)30383-8"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.1339","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,12,16]],"date-time":"2023-12-16T12:15:48Z","timestamp":1702728948000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1339"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11]]},"references-count":15,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2023,12]]}},"alternative-id":["10.1002\/cpdd.1339"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.1339","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,11]]},"assertion":[{"value":"2023-03-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-10-01","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-11-01","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}