{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T05:47:07Z","timestamp":1782107227808,"version":"3.54.5"},"reference-count":35,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T00:00:00Z","timestamp":1781740800000},"content-version":"vor","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>QT interval prolongation associated with drug administration is an important consideration in drug development. Patients with COVID\u201019 are at increased risk for cardiac complications, and QT interval prolongation correlates with higher mortality. This Phase 1 study evaluated the safety, tolerability, pharmacokinetics, and potential effects on QT interval corrected for heart rate (QTc) of a single supratherapeutic intravenous dose of remdesivir (600\u2009mg; 3 times the loading dose [200\u2009mg] of the approved regimen) in healthy participants, as well as the safety of its solubilizing excipient sulfobutylether\u2010\u03b2\u2010cyclodextrin. The study included 2 cohorts: a dose\u2010selection cohort (sentinel cohort), followed by a partially blinded, randomized, placebo\u2010 and positive\u2010controlled, 3\u2010period, 6\u2010treatment sequence, single\u2010dose crossover cohort (TQT cohort). The clinical endpoints were adverse events (AEs), laboratory abnormalities, plasma pharmacokinetic parameters of remdesivir and its metabolites, \u0394\u0394QTcF (baseline\u2010adjusted, placebo\u2010corrected QT interval corrected for heart rate using the Fridericia formula) at each postdose time point, and the relationship between \u0394\u0394QTcF and plasma concentrations of remdesivir by concentration\u2010QT analysis. Sixty participants completed the study. Plasma pharmacokinetics of remdesivir and its metabolites showed no significant differences between cohorts. Sulfobutylether\u2010\u03b2\u2010cyclodextrin was cleared within 24\u2009h, with no pharmacokinetic non\u2010linearities observed. The study found no clinically relevant QTc prolongation from remdesivir at a supratherapeutic dose (\u0394\u0394QTcF &lt;\u200910\u2009ms). Most AEs were Grade 1 or 2 in severity. No serious AEs or deaths were reported. These findings suggest that a single 600\u2010mg intravenous dose of remdesivir is generally safe and well tolerated and does not lead to QTc prolongation of safety concern.<\/jats:p>","DOI":"10.1111\/cts.70645","type":"journal-article","created":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T04:10:17Z","timestamp":1781842217000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Thorough\n                    <scp>QT<\/scp>\n                    \/\n                    <scp>QTc<\/scp>\n                    Clinical Study to Evaluate the Effect of Remdesivir on Cardiac Repolarization in Healthy Participants"],"prefix":"10.1111","volume":"19","author":[{"given":"Chi\u2010Chi","family":"Peng","sequence":"first","affiliation":[{"name":"Gilead Sciences, Inc  Foster City California 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