{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T07:19:49Z","timestamp":1773818389558,"version":"3.50.1"},"reference-count":37,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T00:00:00Z","timestamp":1761091200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T00:00:00Z","timestamp":1761091200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Asciminib is the first BCR::ABL1 inhibitor that Specifically Targets the ABL Myristoyl Pocket (STAMP) in patients with chronic myeloid leukemia. This phase 1, two\u2010treatment\u2010period, drug\u2010drug interaction study evaluated the effect of steady\u2010state asciminib on the pharmacokinetics of atorvastatin. A single dose of atorvastatin (20\u00a0mg) was administered on day 1 (period 1: days 1\u20104). On days 5\u201011 (period 2: days 5\u201012), 80\u00a0mg asciminib was administered once daily, with a single dose of atorvastatin co\u2010administered on day 9. Pharmacokinetic sampling for atorvastatin was performed on days 1\u20104 in period 1 and days 9\u201012 in period 2. Twenty\u2010two healthy participants were enrolled. Twenty participants completed the study, and two discontinued due to adverse events (AEs). Asciminib increased the adjusted geometric mean (G\n                    <jats:sub>mean<\/jats:sub>\n                    ) of maximum plasma concentration (C\n                    <jats:sub>max<\/jats:sub>\n                    ), the area under the curve (AUC) from zero to the last quantifiable concentration (AUC\n                    <jats:sub>last<\/jats:sub>\n                    ), and the AUC from zero to infinity (AUC\n                    <jats:sub>inf<\/jats:sub>\n                    ) of atorvastatin by 24%, 16%, and 14%, respectively, and did not affect these parameters for its active metabolites,\n                    <jats:italic>o<\/jats:italic>\n                    \u2010hydroxy\u2010atorvastatin and\n                    <jats:italic>p<\/jats:italic>\n                    \u2010hydroxy\u2010atorvastatin. Plasma concentrations of coproporphyrin\u20101 (CP\u20101), an endogenous substrate of the atorvastatin transporter OATP1B, were not affected by asciminib. Thirteen participants reported at least one AE, all being grade 1\/2, except for one grade 3 AE (increased alanine aminotransferase). No serious AEs were reported. In conclusion, concomitant administration of steady\u2010state asciminib and atorvastatin resulted in a small, clinically irrelevant increase in atorvastatin exposure and no change in CP\u20101 concentrations. Both drugs were well tolerated. These data support co\u2010administration of asciminib and atorvastatin.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.1611","type":"journal-article","created":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T15:04:28Z","timestamp":1761145468000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Assessment of Pharmacokinetic Drug Interaction of Asciminib with Atorvastatin in Healthy Participants"],"prefix":"10.1002","volume":"15","author":[{"given":"Matthias","family":"Hoch","sequence":"first","affiliation":[{"name":"Novartis Biomedical Research  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wendy","family":"Weis","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals  East Hanover New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Felix","family":"Huth","sequence":"additional","affiliation":[{"name":"Novartis Biomedical Research  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seshulatha","family":"Jamalapuram","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals  East Hanover New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michelle","family":"Quinlan","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals  East Hanover New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amarnath","family":"Bandaru","sequence":"additional","affiliation":[{"name":"Novartis Healthcare Pvt Ltd  Hyderabad India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suleyman Eralp","family":"Bellibas","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals  East Hanover New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Asmae","family":"Mirkou","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shruti","family":"Kapoor","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals  East Hanover New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shefali","family":"Kakar","sequence":"additional","affiliation":[{"name":"Novartis Pharmaceuticals  East Hanover New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,10,22]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.5306\/wjco.v12.i2.69"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.25792"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/243290a0"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.beha.2020.101194"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40487-019-00098-w"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.leukres.2020.106458"},{"key":"e_1_2_10_8_1","unstructured":"Scemblix summary of product characteristics.Novartis.2024. 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