{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T09:51:51Z","timestamp":1791971511479,"version":"4.3.4"},"reference-count":25,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T00:00:00Z","timestamp":1788393600000},"content-version":"vor","delay-in-days":2,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"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":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2026,9]]},"abstract":"Abstract<\/jats:title>\n \n Balcinrenone (AZD9977) is a novel selective non\u2010steroidal mineralocorticoid receptor antagonist with a distinct mode of action being developed as a fixed\u2010dose combination with the sodium\u2013glucose cotransporter\u20102 inhibitor dapagliflozin for the treatment of heart failure with impaired kidney function, and chronic kidney disease. In this Phase 1 randomized open\u2010label three\u2010way crossover study we investigated the effect of food on balcinrenone\/dapagliflozin pharmacokinetics, and the pharmacokinetics of balcinrenone when dosed with a P\u2010glycoprotein (P\u2010gp) inhibitor. Fourteen healthy participants were administered an oral capsule of balcinrenone\/dapagliflozin 40 mg\/10 mg in three dosing periods: fasted (reference), fed (high\u2010fat, high\u2010calorie meal) and with a P\u2010gp inhibitor (quinidine 300 mg \u00d7 2). Balcinrenone exposure was comparable in the fed and fasted states (geometric mean ratios [GMRs] [90% CI]: maximum plasma concentration [C\n max<\/jats:sub>\n ] 1.05 [0.88, 1.25]; area under the plasma concentration\u2013time curve from time 0 to infinity [AUC\n inf<\/jats:sub>\n ] 1.12 [1.06, 1.19]). In the fed state, dapagliflozin AUC\n inf<\/jats:sub>\n was comparable to the fasted state (GMR [90% CI] 1.05 [1.01, 1.09]), whereas C\n max<\/jats:sub>\n was decreased (GMR [90% CI] 0.59 [0.51, 0.69]), in line with previous dapagliflozin food interaction studies. Co\u2010administration with quinidine increased balcinrenone exposure: GMRs (90% CI) 1.48 (1.24, 1.76) and 1.24 (1.17, 1.31) for C\n max<\/jats:sub>\n and AUC\n inf<\/jats:sub>\n , respectively, but AUC fold increase was <2, the level used for classification of sensitive P\u2010gp substrates. All interventions were well tolerated. In conclusion, this study supports dosing of balcinrenone\/dapagliflozin without regard to food. Balcinrenone is not considered a sensitive P\u2010gp substrate. No P\u2010gp based dosing precautions are warranted based on this study.\n <\/jats:p>","DOI":"10.1002\/jcph.70282","type":"journal-article","created":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T07:14:51Z","timestamp":1788419691000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Effect of Food on Balcinrenone\/Dapagliflozin Pharmacokinetics and the Pharmacokinetics of Balcinrenone When Dosed with a P\u2010gp Inhibitor"],"prefix":"10.1002","volume":"66","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 AstraZeneca BioPharmaceuticals R&D Gothenburg 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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":"Edward","family":"Austin","sequence":"additional","affiliation":[{"name":"R&D Biopharmaceuticals, AstraZeneca Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bosse","family":"Lindmark","sequence":"additional","affiliation":[{"name":"Drug Metabolism and Pharmacokinetics Research and Early Development, Cardiovascular, Renal and Metabolism Biopharmaceuticals R&D, AstraZeneca Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4750-4230","authenticated-orcid":false,"given":"Charlotta","family":"Vedin\u2010Nilsson","sequence":"additional","affiliation":[{"name":"Drug Metabolism and Pharmacokinetics Research and Early Development, Cardiovascular, Renal and Metabolism Biopharmaceuticals R&D, AstraZeneca Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Hartleib\u2010Geschwindner","sequence":"additional","affiliation":[{"name":"Late\u2010Stage Clinical Development Cardiovascular Renal and Metabolism AstraZeneca BioPharmaceuticals R&D Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Leonsson\u2010Zachrisson","sequence":"additional","affiliation":[{"name":"Late\u2010Stage Clinical Development Cardiovascular Renal and Metabolism AstraZeneca BioPharmaceuticals R&D 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 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