{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T18:58:39Z","timestamp":1790621919427,"version":"4.1.0"},"reference-count":25,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T00:00:00Z","timestamp":1783036800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T00:00:00Z","timestamp":1783036800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2026,10]]},"abstract":"Abstract<\/jats:title>\n \n Aim<\/jats:title>\n Balcinrenone (previously AZD9977) is a novel selective non\u2010steroidal mineralocorticoid receptor antagonist (MRA) with a differential mechanism of action relative to approved MRAs. The aim of this trial was to assess the pharmacokinetics, safety and tolerability of balcinrenone in participants with mild and moderate hepatic impairment versus participants with normal hepatic function.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Participants with mild and moderate hepatic impairment (Child\u2013Pugh Class A [\n n<\/jats:italic>\n \u2009=\u20098] and Child\u2013Pugh Class B [\n n<\/jats:italic>\n \u2009=\u20098]) were compared with group matched controls with normal hepatic function [\n n<\/jats:italic>\n \u2009=\u20099]. Eligible participants received a single oral dose of 50\u2010mg balcinrenone. Blood and urine samples were collected. Safety and tolerability were monitored.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n In participants with mild hepatic impairment, balcinrenone exposure (area under the plasma concentration\u2013time curve [AUC] and maximum plasma concentration [\n C<\/jats:italic>\n max<\/jats:sub>\n ]) was similar compared with participants with normal hepatic function. In participants with moderate hepatic impairment,\n C<\/jats:italic>\n max<\/jats:sub>\n was similar, but there was a slight and statistically significant 30% (90% CI 4%\u201361%) increase in AUC compared with participants with normal hepatic function. Balcinrenone was well tolerated. All reported adverse events were of mild to moderate intensity.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n Compared with participants with normal hepatic function, balcinrenone exposure was similar in participants with mild hepatic impairment. AUC, but not\n C<\/jats:italic>\n max<\/jats:sub>\n , was slightly increased in participants with moderate hepatic impairment. We do not consider the minor AUC increase seen in participants with moderate hepatic impairment to be clinically relevant. Thus, we would not recommend any dose adjustment for patients with mild or moderate hepatic impairment.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1002\/bcp.70670","type":"journal-article","created":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T09:28:32Z","timestamp":1783070912000},"page":"3656-3665","source":"Crossref","is-referenced-by-count":0,"title":["The effect of mild and moderate hepatic impairment on the pharmacokinetics, safety and tolerability of balcinrenone"],"prefix":"10.1002","volume":"92","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5455-2810","authenticated-orcid":false,"given":"Anna L.","family":"Eriksson","sequence":"first","affiliation":[{"name":"Late\u2010stage Clinical Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D AstraZeneca Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deeyen","family":"Karsanji","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D AstraZeneca Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bonifride","family":"Tuyishimire","sequence":"additional","affiliation":[{"name":"Biometrics, Late Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D AstraZeneca Gaithersburg Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4492-5243","authenticated-orcid":false,"given":"Joanna","family":"Parkinson","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D AstraZeneca Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Heijer","sequence":"additional","affiliation":[{"name":"Integrated Bioanalysis, Clinical Pharmacology and Safety Sciences, R&D AstraZeneca Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadeusz","family":"Pawlik","sequence":"additional","affiliation":[{"name":"Late\u2010stage Clinical Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals R&D AstraZeneca Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Hartleib\u2010Geschwindner","sequence":"additional","affiliation":[{"name":"Late\u2010stage Clinical Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D AstraZeneca Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Leonsson\u2010Zachrisson","sequence":"additional","affiliation":[{"name":"Late\u2010stage Clinical Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D AstraZeneca Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6038-4331","authenticated-orcid":false,"given":"Hans","family":"Ericsson","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D AstraZeneca Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,3]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.21037\/amj.2020.03.03"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.03150509"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.08.036"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000001063"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehad195"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehaa736"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2019.11.014"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0193380"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/ejhf.3294"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(25)02014\u20108"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12705"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13562"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.122.001240"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/bcp.70017"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2011.09.011"},{"key":"e_1_2_11_17_1","unstructured":"EMA.Dapagliflozin: EMA summary of product characteristics. 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