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Part 1: male participants received single doses of placebo or fezolinetant 15 or 60 mg. Part 2: male and premenopausal and postmenopausal female participants received a single dose of placebo or fezolinetant 180 mg, followed by a 2\u2010day washout, and multiple dosing once daily for 10 days. Fezolinetant was rapidly absorbed with peak concentrations 1\u20102 hours after single\u2010dose administration; plasma levels subsequently declined (half\u2010life range, 3.29\u20107.24 hours). Only slight accumulation (area under the concentration\u2013time curve accumulation ratio, 1.46\u20101.57) was observed after once\u2010daily multiple\u2010dose administration. No serious\/severe treatment\u2010emergent adverse events were observed; the only fezolinetant\u2010related treatment\u2010emergent adverse event was mild uterine bleeding in 1 premenopausal woman and 1 postmenopausal woman. Concentration\u2010QT analysis showed that fezolinetant does not have a clinically significant effect on QT interval. Fezolinetant produced dose\u2010dependent reductions in luteinizing hormone and slight reductions in follicle\u2010stimulating hormone; levels subsequently returned to baseline 48 hours or fewer after dosing. This analysis shows that fezolinetant doses up to 180\u00a0mg had an acceptable safety, pharmacokinetic, and biomarker profile. This study clarifies the safety, pharmacokinetic, and biomarker profiles of fezolinetant in Japanese individuals.<\/jats:p>","DOI":"10.1002\/cpdd.1593","type":"journal-article","created":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T20:18:20Z","timestamp":1757708300000},"page":"934-950","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetics, Tolerability, and Biomarker Profile of the Neurokinin 3 Receptor Antagonist Fezolinetant in Healthy Japanese Individuals: A 2\u2010Part, Randomized, Phase 1 Study"],"prefix":"10.1002","volume":"14","author":[{"given":"Akira","family":"Koibuchi","sequence":"first","affiliation":[{"name":"Astellas Pharma Inc.  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