{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T23:57:04Z","timestamp":1784937424392,"version":"3.55.0"},"reference-count":18,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2018,11,9]],"date-time":"2018-11-09T00:00:00Z","timestamp":1541721600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004324","name":"Astellas Pharma US","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004324","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2019,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Amenamevir is an inhibitor of the helicase\u2010primase enzyme complex developed for the treatment of varicella zoster virus. This mass balance study investigated the absorption, metabolism, and excretion of a single dose (200\u00a0mg) of <jats:sup>14<\/jats:sup>C\u2010labeled amenamevir in healthy male volunteers. Blood, urine, and feces samples were collected for up to 8 days after the dose. Safety and tolerability were assessed through voluntary reporting of adverse events, physical examination, and clinical laboratory testing. Amenamevir was rapidly absorbed, with a median time to peak drug concentration of 1.0 to 1.5\u00a0hours and a plasma half\u2010life of 8 to 9\u00a0hours. Overall, 95.3% of the administered dose was recovered, with the majority of radiolabeled drug excreted in feces (74.6%) followed by urine (20.6%). The major route of elimination was fecal, with around 70% of the dose excreted as metabolites and &lt;0.1% as the unchanged drug. Metabolic profiling revealed that predominantly radiolabeled amenamevir (80%) and its hydroxyl metabolite R5 (up to 7.1%) were present in plasma. Single\u2010dose amenamevir was well tolerated; 3 transient and mild adverse events were reported in 3 subjects. Overall, &gt;95% of a single 200\u2010mg dose of amenamevir was eliminated by 168\u00a0hours after the dose, with the major route of elimination being fecal.<\/jats:p>","DOI":"10.1002\/cpdd.630","type":"journal-article","created":{"date-parts":[[2018,11,9]],"date-time":"2018-11-09T14:16:16Z","timestamp":1541772976000},"page":"595-602","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["An Open\u2010Label, Single\u2010Dose, Human Mass Balance Study of Amenamevir in Healthy Male Adults"],"prefix":"10.1002","volume":"8","author":[{"given":"Kota","family":"Kato","sequence":"first","affiliation":[{"name":"Astellas Pharma Inc.  Tsukuba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"den Adel","sequence":"additional","affiliation":[{"name":"Astellas Pharma Europe B.V.  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dorien","family":"Groenendaal\u2010van de Meent","sequence":"additional","affiliation":[{"name":"Astellas Pharma Europe B.V.  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiaki","family":"Ohtsu","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc.  Tsukuba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akitsugu","family":"Takada","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masataka","family":"Katashima","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc.  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