{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T10:11:31Z","timestamp":1789726291260,"version":"4.0.1"},"reference-count":19,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,7,16]],"date-time":"2024-07-16T00:00:00Z","timestamp":1721088000000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Obstructive hypertrophic cardiomyopathy (oHCM) is a subtype of HCM characterized by left ventricular outflow tract obstruction resulting from cardiac muscle hypertrophy and anatomic alterations in the mitral valve and apparatus. Mavacamten, a cardiac myosin inhibitor metabolized primarily by CYP2C19 in the liver, is the first and only targeted medication approved for the treatment of symptomatic New York Heart Association (NYHA) class II\u2013III oHCM. Previous pharmacokinetic (PK) results of mavacamten in healthy Caucasian, Japanese, and Asian participants demonstrated that mavacamten exposure was affected by CYP2C19 metabolism status. This open\u2010label, parallel\u2010group, phase I trial aimed to determine the PK and safety of mavacamten in healthy Chinese participants with different CYP2C19 genotypes. The primary outcome was to define the PK of mavacamten in healthy Chinese participants; the secondary outcome was to examine safety and tolerability. After a single oral dose of 15 or 25\u2009mg mavacamten in fasted healthy adult Chinese individuals, <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> was reached within a median <jats:italic>T<\/jats:italic><jats:sub>max<\/jats:sub> of 0.6\u20131.5\u2009h, indicating rapid absorption. Inter\u2010individual variability was moderate, and individuals carrying non\u2010functional CYP2C19 alleles (*2\/*2, *3\/*3, or *2\/*3) exhibited longer half\u2010life and increased total exposure. After stratification of CYP2C19 genotypes, total mavacamten exposures were similar among different ethnic groups when compared with prior PK studies. No significant adverse events were observed in this study. Single oral administration of mavacamten at 15\u2009mg was well tolerated across all CYP2C19 genotypes, and 25\u2009mg dose was well tolerated in healthy participants with CYP2C19 genotypes UM\/RM\/NM. The PK profile of mavacamten in the healthy Chinese population was consistent with that in other healthy populations.<\/jats:p>","DOI":"10.1111\/cts.13877","type":"journal-article","created":{"date-parts":[[2024,7,17]],"date-time":"2024-07-17T05:04:24Z","timestamp":1721192664000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Pharmacokinetics and safety of mavacamten in healthy Chinese participants with different <scp>CYP2C19<\/scp> phenotypes"],"prefix":"10.1111","volume":"17","author":[{"given":"Xiaojie","family":"Wu","sequence":"first","affiliation":[{"name":"Phase 1 Clinical Research Center Huashan Hospital, Fudan University  Shanghai China"},{"name":"National Clinical Research Center for Aging and Medicine Huashan Hospital, Fudan University  Shanghai China"},{"name":"Research Ward of Huashan Hospital Fudan University  Shanghai 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