{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,1,26]],"date-time":"2024-01-26T06:41:09Z","timestamp":1706251269354},"reference-count":20,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2020,9,15]],"date-time":"2020-09-15T00:00:00Z","timestamp":1600128000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100011096","name":"Jazz Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011096","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":[[2021,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Solriamfetol, a dopamine and norepinephrine reuptake inhibitor, is approved (United States and European Union; Sunosi) to treat excessive daytime sleepiness associated with narcolepsy (75\u2010150\u00a0mg\/day) or obstructive sleep apnea (37.5\u2010150\u00a0mg\/day). A thorough QT\/QTc study assessed solriamfetol effects on QT interval (Fridericia correction for heart rate; QTcF). This randomized, double\u2010blind, placebo\u2010 and positive\u2010controlled, 4\u2010period crossover study compared single doses of 300 and 900\u00a0mg solriamfetol, 400\u00a0mg moxifloxacin, and placebo in healthy adults. Placebo\u2010 and predose\u2010adjusted mean differences in QTcF (ddQTcF; primary end point) were analyzed, and solriamfetol pharmacokinetics were characterized. Fifty\u2010five participants completed all periods. Upper bounds of 2\u2010sided 90% confidence intervals (CIs) for ddQTcF for both solriamfetol doses were &lt;10 milliseconds at all postdose time points. Assay sensitivity was demonstrated with moxifloxacin; lower bounds of 2\u2010sided 90%CIs for ddQTcF &gt; 5 milliseconds at 1, 2, and 3 hours postdose. There were no QTcF increases &gt; 60 milliseconds or QTcF values &gt; 480 milliseconds at either solriamfetol dose. Solriamfetol median t<jats:sub>max<\/jats:sub> was 2\u20103 hours; exposure was dose\u2010proportional. More participants experienced adverse events (AEs) after solriamfetol 900 versus 300\u00a0mg (70% vs 29%); none were serious (all mild\/moderate), and there were no deaths. Common AEs were nausea, dizziness, and palpitations. Neither solriamfetol dose resulted in QTcF prolongation &gt; 10 milliseconds.<\/jats:p>","DOI":"10.1002\/cpdd.867","type":"journal-article","created":{"date-parts":[[2020,9,25]],"date-time":"2020-09-25T11:47:15Z","timestamp":1601034435000},"page":"404-413","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A Randomized, Double\u2010Blind, Placebo\u2010 and Positive\u2010Controlled, 4\u2010Period Crossover Study of the Effects of Solriamfetol on QTcF Intervals in Healthy Participants"],"prefix":"10.1002","volume":"10","author":[{"given":"Katie","family":"Zomorodi","sequence":"first","affiliation":[{"name":"Jazz Pharmaceuticals  Palo Alto California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan","family":"Chen","sequence":"additional","affiliation":[{"name":"Jazz Pharmaceuticals  Palo Alto California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lawrence","family":"Lee","sequence":"additional","affiliation":[{"name":"Jazz Pharmaceuticals  Palo Alto California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dennis","family":"Swearingen","sequence":"additional","affiliation":[{"name":"Celerion  Tempe Arizona USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lawrence P.","family":"Carter","sequence":"additional","affiliation":[{"name":"Jazz Pharmaceuticals  Palo Alto California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,9,15]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.118.248120"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2019.09.001"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-019-00689-1"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1513\/AnnalsATS.202002-136OC"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2018.12.001"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1402"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201806-1100OC"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2018.11.005"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/ana.25423"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/zsz220"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/0269881118796814"},{"key":"e_1_2_11_13_1","unstructured":"Food and Drug Administration. Guidance for industry E14 clinical evaluation of QT\/QTc interval prolongation and proarrhythmic potential for non\u2010antiarrhythmic drugs.2005.https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm073153.pdf. Accessed February 27 2019."},{"key":"e_1_2_11_14_1","unstructured":"International Council for Harmonisation. ICH harmonised tripartite guideline: the clinical evaluation of QT\/QTc interval prolongation and proarrhythmic potential for non\u2010antiarrhythmic drugs E14.2005.https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/e14-clinical-evaluation-qtqtc-interval-prolongation-and-proarrhythmic-potential-non-antiarrhythmic-0. Accessed June 17 2019."},{"issue":"2","key":"e_1_2_11_15_1","first-page":"149","article-title":"Experimental designs balanced for the estimation of residual effects of treatments","volume":"2","author":"Williams EJ","year":"1949","journal-title":"Aust J Sci Res"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2018.02.014"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCEP.117.005808"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270008316326"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.acvd.2016.12.011"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.5664\/jcsm.26970"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.5664\/jcsm.27934"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.867","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.867","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.867","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,2]],"date-time":"2023-09-02T04:23:26Z","timestamp":1693628606000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.867"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,9,15]]},"references-count":20,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2021,4]]}},"alternative-id":["10.1002\/cpdd.867"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.867","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,9,15]]},"assertion":[{"value":"2020-05-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-08-17","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-09-15","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}