{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T12:34:03Z","timestamp":1771850043845,"version":"3.50.1"},"reference-count":11,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2017,11,4]],"date-time":"2017-11-04T00:00:00Z","timestamp":1509753600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2017,11,4]],"date-time":"2017-11-04T00:00:00Z","timestamp":1509753600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"name":"Takeda Development Center Americas, Inc."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs R D"],"published-print":{"date-parts":[[2017,12]]},"DOI":"10.1007\/s40268-017-0214-8","type":"journal-article","created":{"date-parts":[[2017,11,4]],"date-time":"2017-11-04T11:00:27Z","timestamp":1509793227000},"page":"631-643","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["A Randomized Multiple Dose Pharmacokinetic Study of a Novel PDE10A Inhibitor TAK-063 in Subjects with Stable Schizophrenia and Japanese Subjects and Modeling of Exposure Relationships to Adverse Events"],"prefix":"10.1007","volume":"17","clinical-trial-number":[{"clinical-trial-number":"nct01879722","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Paul","family":"Goldsmith","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Affinito","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maggie","family":"McCue","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Max","family":"Tsai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stefan","family":"Roepcke","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jinhui","family":"Xie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lev","family":"Gertsik","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas A.","family":"Macek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2017,11,4]]},"reference":[{"issue":"3","key":"214_CR1","doi-asserted-by":"publisher","first-page":"471","DOI":"10.1124\/jpet.114.218552","volume":"352","author":"K Suzuki","year":"2015","unstructured":"Suzuki K, Harada A, Shiraishi E, Kimura H. In vivo pharmacological characterization of TAK-063, a potent and selective phosphodiesterase 10A inhibitor with antipsychotic-like activity in rodents. J Pharmacol Exp Ther. 2015;352(3):471\u20139. doi:10.1124\/jpet.114.218552.","journal-title":"J Pharmacol Exp Ther"},{"key":"214_CR2","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1007\/978-3-642-25761-2_2","volume":"212","author":"N Ginovart","year":"2012","unstructured":"Ginovart N, Kapur S. Role of dopamine D(2) receptors for antipsychotic activity. Handb Exp Pharmacol. 2012;212:27\u201352. doi:10.1007\/978-3-642-25761-2_2.","journal-title":"Handb Exp Pharmacol"},{"issue":"9657","key":"214_CR3","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1016\/S0140-6736(08)61764-X","volume":"373","author":"S Leucht","year":"2009","unstructured":"Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM. Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet. 2009;373(9657):31\u201341. doi:10.1016\/S0140-6736(08)61764-X.","journal-title":"Lancet"},{"issue":"12","key":"214_CR4","doi-asserted-by":"publisher","first-page":"1209","DOI":"10.1056\/NEJMoa051688","volume":"353","author":"JA Lieberman","year":"2005","unstructured":"Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005;353(12):1209\u201323. doi:10.1056\/NEJMoa051688.","journal-title":"N Engl J Med"},{"issue":"9","key":"214_CR5","doi-asserted-by":"publisher","first-page":"2252","DOI":"10.1038\/npp.2016.20","volume":"41","author":"K Suzuki","year":"2016","unstructured":"Suzuki K, Harada A, Suzuki H, Miyamoto M, Kimura H. TAK-063, a PDE10A inhibitor with balanced activation of direct and indirect pathways, provides potent antipsychotic-like effects in multiple paradigms. Neuropsychopharmacology. 2016;41(9):2252\u201362. doi:10.1038\/npp.2016.20.","journal-title":"Neuropsychopharmacology."},{"issue":"21\u201322","key":"214_CR6","doi-asserted-by":"publisher","first-page":"3787","DOI":"10.1007\/s00213-016-4412-9","volume":"233","author":"M Tsai","year":"2016","unstructured":"Tsai M, Chrones L, Xie J, Gevorkyan H, Macek TA. A phase 1 study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-063, a selective PDE10A inhibitor. Psychopharmacology. 2016;233(21\u201322):3787\u201395. doi:10.1007\/s00213-016-4412-9.","journal-title":"Psychopharmacology"},{"issue":"1","key":"214_CR7","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1001\/archpsyc.62.1.19","volume":"62","author":"DC Henderson","year":"2005","unstructured":"Henderson DC, Cagliero E, Copeland PM, Borba CP, Evins E, Hayden D, et al. Glucose metabolism in patients with schizophrenia treated with atypical antipsychotic agents: a frequently sampled intravenous glucose tolerance test and minimal model analysis. Arch Gen Psychiatry. 2005;62(1):19\u201328. doi:10.1001\/archpsyc.62.1.19.","journal-title":"Arch Gen Psychiatry"},{"issue":"4","key":"214_CR8","first-page":"275","volume":"28","author":"G Remington","year":"2003","unstructured":"Remington G. Understanding antipsychotic \u201catypicality\u201d: a clinical and pharmacological moving target. J Psychiatry Neurosci. 2003;28(4):275\u201384.","journal-title":"J Psychiatry Neurosci"},{"issue":"Suppl 5","key":"214_CR9","first-page":"10","volume":"62","author":"NR Cutler","year":"2001","unstructured":"Cutler NR. Pharmacokinetic studies of antipsychotics in healthy volunteers versus patients. J Clin Psychiatry. 2001;62(Suppl 5):10\u20133 (discussion 23\u20134).","journal-title":"J Clin Psychiatry."},{"issue":"1","key":"214_CR10","first-page":"79","volume":"35","author":"T Okuma","year":"1981","unstructured":"Okuma T. Differential sensitivity to the effects of psychotropic drugs: psychotics vs normals; Asian vs Western populations. Folia Psychiatr Neurol Jpn. 1981;35(1):79\u201387.","journal-title":"Folia Psychiatr Neurol Jpn."},{"key":"214_CR11","unstructured":"Tsai M, Goldsmith P, Xie J, Macek TA. Development of PK\/AE models in subjects with schizophrenia and in healthy Japanese and non-Japanese Subjects. Poster presented at: International Society for CNS Clinical Trials and Methodology (ISCTM) 2015 Autumn Conference; August 27\u201329, 2015; Amsterdam, Netherlands."}],"container-title":["Drugs in R&D"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40268-017-0214-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40268-017-0214-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40268-017-0214-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T17:48:18Z","timestamp":1628617698000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40268-017-0214-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,11,4]]},"references-count":11,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2017,12]]}},"alternative-id":["214"],"URL":"https:\/\/doi.org\/10.1007\/s40268-017-0214-8","relation":{},"ISSN":["1174-5886","1179-6901"],"issn-type":[{"value":"1174-5886","type":"print"},{"value":"1179-6901","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,11,4]]},"assertion":[{"value":"4 November 2017","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with Ethical Standards"}},{"value":"The clinical study was funded by Takeda Development Center Americas, Inc. Medical writing assistance was provided by Stephanie Agbu, Ph.D, and Jake Edelstein, Ph.D, of inVentiv Medical Communications and supported by Takeda Development Center Americas, Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Role of funding source"}},{"value":"John Affinito and\u00a0Maggie McCue are employees of Takeda Development Center Americas, Inc., Deerfield, IL. At the time the study was conducted, Max Tsai, Jinhui Xie, and Thomas A. Macek were employees of Takeda Development Center Americas, Inc.; Paul Goldsmith was an employee of Takeda Development Centre Europe Ltd., London, UK; and Stefan Roepcke was an employee of Takeda Pharmaceuticals International GmbH, Z\u00fcrich, Switzerland. Lev Gertsik is an employee of California Clinical Trials Medical Group\/Parexel, Glendale, CA, USA. He is a consultant to Takeda.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"This study is registered as \u201cSafety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK-063 in Participants With Stable Schizophrenia and Healthy Participants\u201d (Clinical Trials ID: NCT01879722).","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Study registration"}}]}}