{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,9,13]],"date-time":"2024-09-13T00:18:16Z","timestamp":1726186696567},"reference-count":14,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,5,16]],"date-time":"2020-05-16T00:00:00Z","timestamp":1589587200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013170","name":"Ono Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013170","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":[[2021,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>This study evaluated the effect of a small\u2010tablet formulation of opicapone for use in clinical trials in Japan on the pharmacokinetics of levodopa (<jats:sc>l<\/jats:sc>\u2010dopa) and 3\u2010O\u2010methyldopa (3\u2010OMD). In an open\u2010label, 3\u2010period, single\u2010sequence crossover phase 1 study in 80 healthy Japanese males (aged 20\u201045 years; body mass index, 18.5 to &lt;30.0\u00a0kg\/m<jats:sup>2<\/jats:sup>), 10\u00a0mg of <jats:sc>l<\/jats:sc>\u2010dopa\/carbidopa 100 was administered 3 times daily on day 0 (period 1) and day 12 (period 3), and opicapone tablets (5, 10, 25, or 50\u00a0mg; n = 20 each group) were administered once daily for 11 days (period 2). During periods 1 and 3, plasma concentrations of <jats:sc>l<\/jats:sc>\u2010dopa and 3\u2010OMD were measured and pharmacokinetic parameters (maximum observed plasma concentration, time at which maximum concentration was observed, area under the plasma concentration\u2013time curve from time 0 to 5 hours [AUC<jats:sub>5h<\/jats:sub>] and from time 0 to 24 hours [AUC<jats:sub>24h<\/jats:sub>] following each dose, terminal half\u2010life) of plasma <jats:sc>l<\/jats:sc>\u2010dopa and 3\u2010OMD were determined along with the geometric mean ratio (period 3\/period 1) of AUC<jats:sub>24h<\/jats:sub> for <jats:sc>l<\/jats:sc>\u2010dopa and 3\u2010OMD. Maximum concentration of <jats:sc>l<\/jats:sc>\u2010dopa for the first, second, or third doses of <jats:sc>l<\/jats:sc>\u2010dopa\/carbidopa did not significantly increase with increasing opicapone dose. The AUC of <jats:sc>l<\/jats:sc>\u2010dopa increased with increasing opicapone dose but tended toward a peak plateau with opicapone doses of 25\u00a0mg and higher. Geometric mean ratios (90% confidence intervals) of AUC<jats:sub>24h<\/jats:sub> were 5\u00a0mg, 1.16 (1.10\u20101.21); 10\u00a0mg, 1.26 (1.23\u20101.30); 25\u00a0mg, 1.51 (1.44\u20101.57); 50\u00a0mg, 1.60 (1.54\u20101.66). Opicapone tablets were well tolerated. In Japanese healthy subjects, increases in plasma exposure to <jats:sc>l<\/jats:sc>\u2010dopa appear to level off with opicapone doses of 25\u00a0mg and higher, which may be relevant for optimal dosing among Japanese patients with Parkinson disease.<\/jats:p>","DOI":"10.1002\/cpdd.799","type":"journal-article","created":{"date-parts":[[2020,5,16]],"date-time":"2020-05-16T19:44:26Z","timestamp":1589658266000},"page":"180-189","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Effect of Opicapone Tablets on Levodopa and 3\u2010O\u2010Methyldopa Pharmacokinetics in Healthy Japanese Subjects: Phase 1 Study"],"prefix":"10.1002","volume":"10","author":[{"given":"Masahiro","family":"Nomoto","sequence":"first","affiliation":[{"name":"Department of Neurology and Clinical Pharmacology Ehime University Graduate School of Medicine  Matsuyama Japan"},{"name":"Department of Neurology Saiseikai Imabari Hospital  Imabari Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atsushi","family":"Takeda","sequence":"additional","affiliation":[{"name":"National Hospital Organization Sendai\u2010Nishitaga Hospital  Sendai Japan"},{"name":"Department of Cognitive &amp; Motor Aging Tohoku University Graduate School of Medicine  Sendai Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katsuaki","family":"Iwai","sequence":"additional","affiliation":[{"name":"Department of Clinical Development Ono Pharmaceutical Co., Ltd.  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akihisa","family":"Nishimura","sequence":"additional","affiliation":[{"name":"Department of Clinical Development Ono Pharmaceutical Co., Ltd.  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nobutaka","family":"Hattori","sequence":"additional","affiliation":[{"name":"Department of Neurology Juntendo University Graduate School of Medicine  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,5,16]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.2217\/nmt-2018-0020"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.2169\/internalmedicine.56.7667"},{"issue":"11","key":"e_1_2_10_4_1","first-page":"S24","article-title":"Issues important for rational COMT inhibition","volume":"55","author":"Dingemanse J","year":"2000","journal-title":"Neurology"},{"issue":"3","key":"e_1_2_10_5_1","first-page":"407","article-title":"Decarboxylase inhibitors","volume":"1","author":"Bartholini G","year":"1975","journal-title":"Pharmacol Ther B"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.33.3.278"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.62.1_suppl_1.S72"},{"issue":"11","key":"e_1_2_10_8_1","first-page":"S65","article-title":"The place of COMT inhibitors in the armamentarium of drugs for the treatment of Parkinson's disease","volume":"55","author":"Schapira AH","year":"2000","journal-title":"Neurology"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-012-0024-7"},{"key":"e_1_2_10_10_1","unstructured":"European Medicines Agency. Ongentys (opicapone) European public assessment report summary.https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/ongentys. Accessed June 27 2019."},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S104227"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-014-1701-2"},{"key":"e_1_2_10_13_1","unstructured":"US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Drug interaction studies: study design data analysis implications for dosing and labeling recommendations.https:\/\/www.xenotech.com\/regulatory-documents\/2012\/2012_guidance.aspx. Accessed June 28 2019."},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.217"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13156"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcpdd.799","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.799","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.799","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.799","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,3]],"date-time":"2023-09-03T18:47:15Z","timestamp":1693766835000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.799"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,5,16]]},"references-count":14,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021,2]]}},"alternative-id":["10.1002\/cpdd.799"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.799","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,5,16]]},"assertion":[{"value":"2020-01-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-03-07","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-05-16","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}