{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,9]],"date-time":"2026-08-09T02:47:11Z","timestamp":1786243631665,"version":"build-2736575974"},"reference-count":13,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2020,1,22]],"date-time":"2020-01-22T00:00:00Z","timestamp":1579651200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009954","name":"Taiho Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009954","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":[[2020,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>TAC\u2010302 stimulates neurite outgrowth activity and is expected to restore urinary function in patients with lower urinary tract dysfunction. We conducted 2 phase 1, randomized, placebo\u2010controlled studies to confirm the safety and pharmacokinetics (PK) of TAC\u2010302 in healthy adult Japanese male volunteers. In the first\u2010in\u2010human single\u2010dose study (n = 60), TAC\u2010302 was administered at doses from 100 to 1200\u00a0mg after an overnight fast. The effects of a meal on the PK of TAC\u2010302 400\u00a0mg were also examined. A multiple\u2010dose study (n = 36) evaluated the effects of meal fat content on the PK of single doses of TAC\u2010302 (100, 200, or 400\u00a0mg) and multiple doses of TAC\u2010302 administered for 5\u00a0days (100, 200, and 400\u00a0mg twice daily). TAC\u2010302 showed linear PK up to doses of 1200\u00a0mg in the fasting state, and across the dose range of 100\u2013400\u00a0mg in the fed state. No accumulation of TAC\u2010302 was observed. Food, particularly with high fat content, increased TAC\u2010302 plasma concentrations. No differences were observed in the adverse event incidence between the TAC\u2010302 and placebo groups in either study. TAC\u2010302 showed a wide safety margin.<\/jats:p>","DOI":"10.1002\/cpdd.776","type":"journal-article","created":{"date-parts":[[2020,1,23]],"date-time":"2020-01-23T07:26:44Z","timestamp":1579764404000},"page":"821-832","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Safety, Tolerability, Pharmacokinetics, and Food Effects on TAC\u2010302 in Healthy Participants: Randomized, Double\u2010Blind, Placebo\u2010Controlled, Single\u2010Dose and Multiple\u2010Dose Studies"],"prefix":"10.1002","volume":"9","author":[{"given":"Shogo","family":"Sesoko","sequence":"first","affiliation":[{"name":"Sosenkai Clinic Edogawa Mizue Edogawa\u2010ku  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinhong","family":"Huang","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Department Taiho Pharmaceutical Co. Ltd. Uchikanda Chiyoda\u2010ku  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashige","family":"Okayama","sequence":"additional","affiliation":[{"name":"Pharmacokinetics Research Laboratories Taiho Pharmaceutical Co. Ltd. Okubo  Tsukuba Ibaraki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erika","family":"Nishida","sequence":"additional","affiliation":[{"name":"Clinical Development II Department Taiho Pharmaceutical Co. Ltd. Uchikanda Chiyoda\u2010ku  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuhisa","family":"Miyoshi","sequence":"additional","affiliation":[{"name":"Clinical Development II Department Taiho Pharmaceutical Co. Ltd. Uchikanda Chiyoda\u2010ku  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,1,22]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0090-4295(02)02243-4"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000000309"},{"issue":"1","key":"e_1_2_10_4_1","first-page":"11","article-title":"The other bladder syndrome: underactive bladder","volume":"15","author":"Miyazato M","year":"2013","journal-title":"Rev Urol"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/luts.12070"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0006-8993(01)03007-4"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.23571"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0024-3205(01)01536-3"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejphar.2004.08.005"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.23375"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1021\/js9600641"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2011.05.046"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/009127009203201205"},{"issue":"4","key":"e_1_2_10_14_1","first-page":"e49","article-title":"Therapeutic effect of TAC\u2010302, a novel neurite outgrowth enhancer, on voiding dysfunction in rats with STZ\u2010induced diabetes [abstract 122]","volume":"189","author":"Noma T","year":"2013","journal-title":"J Urol"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcpdd.776","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.776","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.776","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.776","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,3]],"date-time":"2023-09-03T15:28:58Z","timestamp":1693754938000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.776"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,1,22]]},"references-count":13,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2020,10]]}},"alternative-id":["10.1002\/cpdd.776"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.776","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,1,22]]},"assertion":[{"value":"2019-09-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-12-16","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-01-22","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}