{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T05:15:13Z","timestamp":1773724513760,"version":"3.50.1"},"reference-count":20,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2018,9,19]],"date-time":"2018-09-19T00:00:00Z","timestamp":1537315200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Global Health Investment Fund"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2018,11]]},"abstract":"<jats:p>Potential effects on cardiac repolarization of single doses of moxidectin, a potent long\u2010acting macrocyclic lactone endectocide, were assessed in a concentration\u2010<jats:styled-content style=\"fixed-case\">QT<\/jats:styled-content> (c\u2010QT; exposure\u2010response) study. This double\u2010blind, placebo\u2010controlled, parallel\u2010group study in healthy male volunteers (<jats:italic>n<\/jats:italic>\u00a0=\u00a060) randomized subjects to a single oral dose of moxidectin (4\u00a0mg, 8\u00a0mg, 16\u00a0mg, 24\u00a0mg, or 36\u00a0mg) or matching placebo. Serial plasma samples for pharmacokinetic (PK) analysis and concurrent triplicate electrocardiogram measurements were taken at baseline and 14 prespecified time points over 72\u00a0hours, yielding 900 <jats:styled-content style=\"fixed-case\">QT<\/jats:styled-content> interval\u2010plasma concentration time\u2010matched pairs. Moxidectin had no statistically significant or clinically relevant impact on <jats:styled-content style=\"fixed-case\">QT<\/jats:styled-content> interval at any dose level. The primary mixed effects model analysis revealed no treatment\u2010related impact on the Fridericia\u2010corrected <jats:styled-content style=\"fixed-case\">QT<\/jats:styled-content> interval\u2010plasma concentration gradient (\u22120.0077, 90% confidence interval (<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>) \u22120.0255 to +0.0101).<\/jats:p>","DOI":"10.1111\/cts.12583","type":"journal-article","created":{"date-parts":[[2018,8,17]],"date-time":"2018-08-17T09:51:09Z","timestamp":1534499469000},"page":"582-589","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Evaluation of the Cardiac Safety of Long\u2010Acting Endectocide Moxidectin in a Randomized Concentration\u2010<scp>QT<\/scp> Study"],"prefix":"10.1111","volume":"11","author":[{"given":"Sally A.","family":"Kinrade","sequence":"first","affiliation":[{"name":"Medicines Development for Global Health  Melbourne Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jay W.","family":"Mason","sequence":"additional","affiliation":[{"name":"Mason Cardiac Safety Consulting  Reno Nevada USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos R.","family":"Sanabria","sequence":"additional","affiliation":[{"name":"Spaulding Clinical Research LLC  West Bend Wisconsin USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Craig R.","family":"Rayner","sequence":"additional","affiliation":[{"name":"Certara Strategic Consulting  Melbourne Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julie M.","family":"Bullock","sequence":"additional","affiliation":[{"name":"Certara Strategic Consulting  Melbourne Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie H.","family":"Stanworth","sequence":"additional","affiliation":[{"name":"Mason Cardiac Safety Consulting  Reno Nevada USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark T.","family":"Sullivan","sequence":"additional","affiliation":[{"name":"Medicines Development for Global Health  Melbourne Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,9,19]]},"reference":[{"key":"e_1_2_9_1_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.60"},{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-015-0325-5"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1079\/9780851996172.0125"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10158-016-0190-7"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0020-7519(03)00172-3"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0002953"},{"key":"e_1_2_9_7_1","doi-asserted-by":"crossref","first-page":"1207","DOI":"10.1016\/S0140-6736(17)32844-1","article-title":"Single dose moxidectin versus ivermectin for Onchocerca volvulus infection in Ghana, Liberia, and the Democratic Republic of the Congo: a randomised, controlled, double\u2010blind phase 3 trial","volume":"392","author":"Opoku N.O.","journal-title":"Lancet"},{"key":"e_1_2_9_8_1","unstructured":"Data on file Medicines Development for Global Health."},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270003257456"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/2160763X11432508"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00311-11"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.81"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.2012.11-0415"},{"key":"e_1_2_9_14_1","unstructured":"International Conference on Harmonisation (ICH) E14 The Clinical Evaluation of QT\/QTc Interval Prolongation and Proarrhythmic Potential for Non\u2010Antiarrhythmic Drugs.2005."},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2014.06.003"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/anec.12128"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270007307881"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/anec.12227"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12443"},{"key":"e_1_2_9_20_1","article-title":"Determining the optimal dose of moxidectin for onchocerciasis via pharmacokinetic\u2010pharmacodynamic modelling of data from healthy volunteers and patients with onchocerciasis","author":"Jamsen K.","year":"2017","journal-title":"Am. J. Trop. Med. Hyg."}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fcts.12583","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.12583","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,16]],"date-time":"2023-09-16T11:54:03Z","timestamp":1694865243000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.12583"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,9,19]]},"references-count":20,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2018,11]]}},"alternative-id":["10.1111\/cts.12583"],"URL":"https:\/\/doi.org\/10.1111\/cts.12583","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,9,19]]},"assertion":[{"value":"2018-09-19","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}