{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,28]],"date-time":"2025-07-28T22:05:19Z","timestamp":1753740319201,"version":"3.37.3"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"10","license":[{"start":{"date-parts":[[2022,8,31]],"date-time":"2022-08-31T00:00:00Z","timestamp":1661904000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springer.com\/tdm"},{"start":{"date-parts":[[2022,8,31]],"date-time":"2022-08-31T00:00:00Z","timestamp":1661904000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springer.com\/tdm"}],"funder":[{"DOI":"10.13039\/100005614","name":"Biogen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005614","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Drug Investig"],"published-print":{"date-parts":[[2022,10]]},"DOI":"10.1007\/s40261-022-01194-y","type":"journal-article","created":{"date-parts":[[2022,8,31]],"date-time":"2022-08-31T17:02:31Z","timestamp":1661965351000},"page":"829-837","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of the Effect of Uridine Diphosphate-Glucuronosyltransferases (UGT) Inhibition by Valproic Acid on Vixotrigine Pharmacokinetics in Healthy Volunteers"],"prefix":"10.1007","volume":"42","clinical-trial-number":[{"clinical-trial-number":"nct03385525","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8259-8661","authenticated-orcid":false,"given":"Yuan","family":"Zhao","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mona","family":"Kotecha","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helen","family":"Finnigan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Serenko","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Himanshu","family":"Naik","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,8,31]]},"reference":[{"issue":"6","key":"1194_CR1","doi-asserted-by":"publisher","first-page":"644","DOI":"10.1055\/s-0038-1673679","volume":"38","author":"A Macone","year":"2018","unstructured":"Macone A, Otis JAD. Neuropathic pain. Semin Neurol. 2018;38(6):644\u201353. https:\/\/doi.org\/10.1055\/s-0038-1673679.","journal-title":"Semin Neurol"},{"issue":"2, Selected Top","key":"1194_CR2","doi-asserted-by":"publisher","first-page":"512","DOI":"10.1212\/CON.0000000000000462","volume":"23","author":"LA Zilliox","year":"2017","unstructured":"Zilliox LA. Neuropathic pain. Continuum (Minneap Minn). 2017;23(2, Selected Topics in Outpatient Neurology):512\u201332. https:\/\/doi.org\/10.1212\/CON.0000000000000462.","journal-title":"Continuum (Minneap Minn)"},{"issue":"1\u20132","key":"1194_CR3","doi-asserted-by":"publisher","first-page":"46","DOI":"10.1016\/j.neurol.2018.08.005","volume":"175","author":"N Attal","year":"2019","unstructured":"Attal N. Pharmacological treatments of neuropathic pain: the latest recommendations. Rev Neurol (Paris). 2019;175(1\u20132):46\u201350. https:\/\/doi.org\/10.1016\/j.neurol.2018.08.005.","journal-title":"Rev Neurol (Paris)."},{"issue":"2","key":"1194_CR4","doi-asserted-by":"publisher","first-page":"1079","DOI":"10.1152\/physrev.00052.2017","volume":"99","author":"DL Bennett","year":"2019","unstructured":"Bennett DL, Clark AJ, Huang J, Waxman SG, Dib-Hajj SD. The role of voltage-gated sodium channels in pain signaling. Physiol Rev. 2019;99(2):1079\u2013151. https:\/\/doi.org\/10.1152\/physrev.00052.2017.","journal-title":"Physiol Rev"},{"issue":"4","key":"1194_CR5","doi-asserted-by":"publisher","first-page":"291","DOI":"10.1016\/S1474-4422(17)30005-4","volume":"16","author":"JM Zakrzewska","year":"2017","unstructured":"Zakrzewska JM, Palmer J, Morisset V, Giblin GM, Obermann M, Ettlin DA, et al. Study Investigators. Safety and efficacy of a Nav17 selective sodium channel blocker in patients with trigeminal neuralgia: a double-blind, placebo-controlled, randomised withdrawal phase 2a trial. Lancet Neurol. 2017;16(4):291\u2013300. https:\/\/doi.org\/10.1016\/S1474-4422(17)30005-4.","journal-title":"Lancet Neurol"},{"issue":"4","key":"1194_CR6","doi-asserted-by":"publisher","first-page":"1272","DOI":"10.1111\/cts.12935","volume":"14","author":"H Naik","year":"2021","unstructured":"Naik H, Steiner DJ, Versavel M, Palmer J, Fong R. Safety, tolerability and pharmacokinetics of single and repeat doses of vixotrigine in healthy volunteers. Clin Transl Sci. 2021;14(4):1272\u20139. https:\/\/doi.org\/10.1111\/cts.12935.","journal-title":"Clin Transl Sci"},{"issue":"3","key":"1194_CR7","doi-asserted-by":"publisher","first-page":"395","DOI":"10.1007\/s13318-021-00678-0","volume":"46","author":"H Naik","year":"2021","unstructured":"Naik H, Zhao Y, Forrestal F, Cleall S, Bockbrader H, Chapel S. Population pharmacokinetics of vixotrigine in healthy volunteers and subjects with trigeminal neuralgia, painful lumbosacral radiculopathy and erythromelalgia. Eur J Drug Metab Pharmacokinet. 2021;46(3):395\u2013404. https:\/\/doi.org\/10.1007\/s13318-021-00678-0.","journal-title":"Eur J Drug Metab Pharmacokinet"},{"doi-asserted-by":"crossref","unstructured":"Woodward C, Naik H, Versavel M, et al. Phase 1 study to evaluate the absorption, metabolism and excretion of the NAV1.7-selective sodium channel blocker BIIB074 [poster 162]. Presented at the International Society for the Study of Xenobiotics (ISSX) 21st North American Meeting; 24\u201328 September, 2017; Providence (RI).","key":"1194_CR8","DOI":"10.1016\/j.dmpk.2017.11.245"},{"issue":"1","key":"1194_CR9","doi-asserted-by":"publisher","first-page":"62","DOI":"10.1002\/cpdd.739","volume":"9","author":"J Dunbar","year":"2020","unstructured":"Dunbar J, Versavel M, Zhao Y, Tate S, Morisset V, Giblin GMP, et al. Evaluation of the pharmacokinetic interaction between the voltage- and use-dependent Nav1.7 channel blocker vixotrigine and carbamazepine in healthy volunteers. Clin Pharmacol Drug Dev. 2020;9(1):62\u201373. https:\/\/doi.org\/10.1002\/cpdd.739.","journal-title":"Clin Pharmacol Drug Dev."},{"issue":"1","key":"1194_CR10","doi-asserted-by":"publisher","first-page":"67","DOI":"10.2165\/00003088-198005010-00002","volume":"5","author":"R Gugler","year":"1980","unstructured":"Gugler R, von Unruh GE. Clinical pharmacokinetics of valproic acid. Clin Pharmacokinet. 1980;5(1):67\u201383. https:\/\/doi.org\/10.2165\/00003088-198005010-00002.","journal-title":"Clin Pharmacokinet"},{"issue":"4","key":"1194_CR11","doi-asserted-by":"publisher","first-page":"236","DOI":"10.1097\/FPC.0b013e32835ea0b2","volume":"23","author":"Y Ghodke-Puranik","year":"2013","unstructured":"Ghodke-Puranik Y, Thorn CF, Lamba JK, Leeder JS, Song W, Birnbaum AK, et al. Valproic acid pathway: pharmacokinetics and pharmacodynamics. Pharmacogenet Genomics. 2013;23(4):236\u201341. https:\/\/doi.org\/10.1097\/FPC.0b013e32835ea0b2.","journal-title":"Pharmacogenet Genomics"},{"issue":"2","key":"1194_CR12","doi-asserted-by":"publisher","first-page":"145","DOI":"10.1016\/S0009-9236(96)90130-7","volume":"60","author":"GD Anderson","year":"1996","unstructured":"Anderson GD, Yau MK, Gidal BE, Harris SJ, Levy RH, Lai AA, et al. Bidirectional interaction of valproate and lamotrigine in healthy subjects. Clin Pharmacol Ther. 1996;60(2):145\u201356. https:\/\/doi.org\/10.1016\/S0009-9236(96)90130-7.","journal-title":"Clin Pharmacol Ther"},{"issue":"6","key":"1194_CR13","doi-asserted-by":"publisher","first-page":"779","DOI":"10.1038\/clpt.1980.235","volume":"28","author":"E Perucca","year":"1980","unstructured":"Perucca E, Hebdige S, Frigo GM, Gatti G, Lecchini S, Crema A. Interaction between phenytoin and valproic acid: plasma protein binding and metabolic effects. Clin Pharmacol Ther. 1980;28(6):779\u201389. https:\/\/doi.org\/10.1038\/clpt.1980.235.","journal-title":"Clin Pharmacol Ther"},{"issue":"3","key":"1194_CR14","doi-asserted-by":"publisher","first-page":"272","DOI":"10.1038\/clpt.1994.137","volume":"56","author":"JJ Lertora","year":"1994","unstructured":"Lertora JJ, Rege AB, Greenspan DL, Akula S, George WJ, Hyslop NE Jr, et al. Pharmacokinetic interaction between zidovudine and valproic acid in patients infected with human immunodeficiency virus. Clin Pharmacol Ther. 1994;56(3):272\u20138. https:\/\/doi.org\/10.1038\/clpt.1994.137.","journal-title":"Clin Pharmacol Ther"},{"unstructured":"US Food and Drug Administration. FDA draft guidance 2012. Drug interaction studies-study design, data analysis, implications for dosing, and labeling recommendations. Silver Spring, MD: FDA.","key":"1194_CR15"},{"unstructured":"US Department of Health and Human Services, US Food and Drug Administration. Guidance for industry: statistical approaches to establishing bioequivalence. 2001. Rockville, MD: FDA.","key":"1194_CR16"},{"issue":"9","key":"1194_CR17","doi-asserted-by":"publisher","first-page":"1441","DOI":"10.1016\/s0006-2952(03)00076-5","volume":"65","author":"BT Ethell","year":"2003","unstructured":"Ethell BT, Anderson GD, Burchell B. The effect of valproic acid on drug and steroid glucuronidation by expressed human UDP-glucuronosyltransferases. Biochem Pharmacol. 2003;65(9):1441\u20139. https:\/\/doi.org\/10.1016\/s0006-2952(03)00076-5.","journal-title":"Biochem Pharmacol"},{"issue":"4","key":"1194_CR18","doi-asserted-by":"publisher","first-page":"409","DOI":"10.1684\/epd.2014.0714","volume":"16","author":"G Zaccara","year":"2014","unstructured":"Zaccara G, Perucca E. Interactions between antiepileptic drugs, and between antiepileptic drugs and other drugs. Epileptic Disord. 2014;16(4):409\u201331. https:\/\/doi.org\/10.1684\/epd.2014.0714.","journal-title":"Epileptic Disord"}],"container-title":["Clinical Drug Investigation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40261-022-01194-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40261-022-01194-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40261-022-01194-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,10,5]],"date-time":"2022-10-05T18:19:19Z","timestamp":1664993959000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40261-022-01194-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,31]]},"references-count":18,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2022,10]]}},"alternative-id":["1194"],"URL":"https:\/\/doi.org\/10.1007\/s40261-022-01194-y","relation":{},"ISSN":["1173-2563","1179-1918"],"issn-type":[{"type":"print","value":"1173-2563"},{"type":"electronic","value":"1179-1918"}],"subject":[],"published":{"date-parts":[[2022,8,31]]},"assertion":[{"value":"16 August 2022","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"31 August 2022","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The clinical study was funded by Biogen.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"YZ, MK, HF, MS, and HN: present or prior employees of and own stock\/stock options in Biogen.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The trial was registered at ClinicalTrials.gov (NCT03385525) and conducted in accordance with the Declaration of Helsinki principles and Good Clinical Practice guidelines. The institutional review board of the clinical site (Covance Clinical Research Unit, Alice, TX, USA) provided approval of the protocol.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All participants provided informed written consent.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The data that support this clinical study are available upon reasonable request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"YZ and HN led the study design, data interpretation, and manuscript preparation. All authors contributed to the study execution and data analysis, and reviewed and provided input on the manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}