{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T02:15:57Z","timestamp":1792808157653,"version":"4.5.0"},"reference-count":42,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,6,24]],"date-time":"2025-06-24T00:00:00Z","timestamp":1750723200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Imlunestrant (LY3484356) is a next\u2010generation orally bioavailable selective estrogen receptor degrader being investigated for the treatment of estrogen receptor\u2013positive advanced breast and endometrial cancers. This Phase 1, open\u2010label, 2\u2010part study evaluated the disposition and absolute bioavailability of [\n                    <jats:sup>14<\/jats:sup>\n                    C]\u2010imlunestrant in 16 US\u2010based healthy women (aged 36\u201065 years) of non\u2013childbearing potential. Part 1 participants (N = 8) received an oral dose of 400\u2010mg [\n                    <jats:sup>14<\/jats:sup>\n                    C]\u2010imlunestrant solution (100 \u00b5Ci). Part 2 participants (N = 8) received an oral dose of 2\u00a0\u00d7\u00a0200\u2010mg imlunestrant tablets followed by approximately 45\u00a0\u00b5g [\n                    <jats:sup>14<\/jats:sup>\n                    C]\u2010imlunestrant (approximately 1 \u00b5Ci) given as a 15\u2010minutes infusion 4 hour later. Blood, fecal, and urine samples were collected. Total radioactivity was primarily eliminated in feces (97.3%) with trace amounts recovered in urine (0.278%), suggesting minimal renal clearance. Imlunestrant accounted for most of the radioactive dose in feces (61.8%), followed by metabolite M2 (20.9%), metabolites M5\u00a0+\u00a0M10 (coeluted), M7, M8, M9, and M11 (5.1% or less for each). Absolute bioavailability of imlunestrant after oral administration relative to intravenous administration was 10.9% based on dose\u2010normalized area under the concentration\u2013time curve from time zero to infinite time. Imlunestrant was well tolerated as an oral solution or as a tablet\/intravenous dose. Eight participants reported mild\/moderate treatment\u2010related adverse events that resolved by the end of the study.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.1562","type":"journal-article","created":{"date-parts":[[2025,6,24]],"date-time":"2025-06-24T04:50:04Z","timestamp":1750740604000},"page":"764-775","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Disposition and Absolute Bioavailability of Oral Imlunestrant in Healthy Women: A Phase 1, Open\u2010Label Study"],"prefix":"10.1002","volume":"14","author":[{"given":"Amita","family":"Datta\u2010Mannan","sequence":"first","affiliation":[{"name":"Eli Lilly and Company  Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boris","family":"Czeskis","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elaine","family":"Shanks","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Bracknell Berkshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eunice","family":"Yuen","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Bracknell Berkshire UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Hall","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivian","family":"Rodriguez Cruz","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth","family":"Cassidy","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company  Indianapolis IN 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OT\u201009\u201003: EMBER: a phase 1a\/b trial of LY3484356, a novel, oral selective estrogen\u2010receptor degrader (SERD), in advanced ER+ breast cancer and endometroid endometrial cancer","volume":"81","author":"Lim E","year":"2021","journal-title":"Cancer Res"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.23.02733"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2410858"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.3390\/molecules28248038"},{"key":"e_1_2_10_36_1","doi-asserted-by":"publisher","DOI":"10.1080\/03602530600952172"},{"key":"e_1_2_10_37_1","doi-asserted-by":"publisher","DOI":"10.1002\/bdd.661"},{"key":"e_1_2_10_38_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2022.40.16_suppl.1021"},{"issue":"4","key":"e_1_2_10_39_1","article-title":"EMBER\u20103: a randomized phase 3 study of LY3484356, a novel, oral selective estrogen receptor degrader vs investigator's choice of endocrine therapy of 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