{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T03:09:26Z","timestamp":1788318566427,"version":"build-2803163510"},"reference-count":17,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2023,9,8]],"date-time":"2023-09-08T00:00:00Z","timestamp":1694131200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Triclabendazole is an effective and well\u2010tolerated treatment for human fascioliasis. A placebo\u2010 and positive\u2010controlled, four\u2010sequence by four\u2010period crossover study was conducted in 45 healthy participants to assess the effect of therapeutic (10\u2009mg\/kg twice daily [b.i.d.] for 1\u2009day) and supratherapeutic (10\u2009mg\/kg b.i.d. for 3\u2009days) oral doses of triclabendazole on corrected QT (QTc) interval prolongation. Moxifloxacin (400\u2009mg, oral) was used as a positive control. The highest mean placebo\u2010corrected change from baseline in QTcF (\u0394\u0394QTcF) on day 4 with triclabendazole was 9.2 at therapeutic dose ms and 21.7\u2009ms at supratherapeutic dose, at 4\u2009h postdose. The upper limit of the two\u2010sided 90% confidence interval exceeded 10\u2009ms across all timepoints, except at predose timepoint on day 4 in the therapeutic group indicating that an effect of triclabendazole on cardiac repolarization could not be excluded. However, triclabendazole had no clinically significant effects on heart rate and cardiac conduction at the studied doses. In the moxifloxacin group, the mean \u0394\u0394QTcF peak value was 13.7\u2009ms at 3\u2009h on day 4. The assay sensitivity was confirmed. Maximum plasma concentration of triclabendazole, sulfoxide metabolite, and sulfone metabolite occurred at ~3\u2010, 4\u2010, and 6\u2010h postdose, respectively. No deaths, serious adverse events, study discontinuations due to treatment\u2010emergent adverse events, or clinically relevant abnormalities in laboratory evaluations and vital sign values were observed. This study showed that triclabendazole had no clinically relevant effects on heart rate and cardiac conduction; however, an effect on cardiac repolarization (\u0394\u0394QTcF &gt;10\u2009ms) could not be excluded.<\/jats:p>","DOI":"10.1111\/cts.13564","type":"journal-article","created":{"date-parts":[[2023,9,9]],"date-time":"2023-09-09T06:12:57Z","timestamp":1694239977000},"page":"1758-1767","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Effects of triclabendazole and its metabolite exposure on the heart\u2010rate\u2013corrected QT intervals: A randomized, placebo\u2010 and positive\u2010controlled thorough QT study in healthy individuals"],"prefix":"10.1111","volume":"16","author":[{"given":"William T.","family":"Prince","sequence":"first","affiliation":[{"name":"Novartis Institutes for Biomedical Research, Novartis Pharmaceuticals Corporation  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinay Kumar","family":"Venishetty","sequence":"additional","affiliation":[{"name":"Novartis Institutes for Biomedical Research Novartis Healthcare Private Limited  Hyderabad India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"Lecot","sequence":"additional","affiliation":[{"name":"Novartis Institutes for Biomedical Research, Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kasra","family":"Shakeri\u2010Nejad","sequence":"additional","affiliation":[{"name":"Novartis Institutes for Biomedical Research, Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cathy","family":"Gray","sequence":"additional","affiliation":[{"name":"Novartis Institutes for Biomedical Research Novartis Pharmaceuticals Corporation  East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amanda","family":"Taylor","sequence":"additional","affiliation":[{"name":"Novartis Institutes for Biomedical Research Novartis Pharmaceuticals Corporation  East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ganesh R.","family":"Iyer","sequence":"additional","affiliation":[{"name":"Novartis Institutes for Biomedical Research, Novartis Pharmaceuticals Corporation  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Zack","sequence":"additional","affiliation":[{"name":"Novartis Institutes for Biomedical Research Novartis Pharmaceuticals Corporation  East Hanover New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,9,8]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1517\/13543784.14.12.1513"},{"key":"e_1_2_10_3_1","unstructured":"CDC\u2013Fasciola\u2013Resources for Health Professionals.https:\/\/www.cdc.gov\/parasites\/fasciola\/health_professionals\/index.html#tx. 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