{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T20:14:14Z","timestamp":1784664854641,"version":"3.55.0"},"reference-count":20,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2024,10,17]],"date-time":"2024-10-17T00:00:00Z","timestamp":1729123200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Vatiquinone, a 15\u2010lipoxygenase inhibitor, is in development for patients with Friedreich ataxia. The study determined the effect of vatiquinone on electrocardiogram parameters. This was a 2\u2010part, single\u2010center, randomized, double\u2010blinded, and placebo\u2010controlled study. Part 1 used an adaptive approach to identify a supratherapeutic dose, while Part 2 evaluated the effect of vatiquinone on Fridericia corrected QT interval (QTcF). A safe and tolerated supratherapeutic dose of 1400\u00a0mg was identified. Concentration\u2010QTcF analysis confirmed there was no statistically significant relationship between vatiquinone concentration and QTcF. QTcF effect (ie, \u0394\u0394QTcF) exceeding 10\u00a0milliseconds was excluded for concentrations up to approximately 11,500\u00a0ng\/mL. By\u2010time\u2010point analysis confirmed that least\u2010squares mean \u0394\u0394QTcF was below 10\u00a0milliseconds. Largest least\u2010squares mean \u0394\u0394QTcF of 1.5\u00a0milliseconds was observed at 2\u00a0hours after dosing. Vatiquinone did not have a clinically relevant effect on heart rate nor on cardiac conduction (PR interval and QRS interval). No new safety signals were found, as safety data are consistent with the known safety profile of vatiquinone. These findings altogether demonstrated that there is a minimal cardiac risk for vatiquinone concentrations up to the supratherapeutic dose level.<\/jats:p>","DOI":"10.1002\/cpdd.1476","type":"journal-article","created":{"date-parts":[[2024,10,17]],"date-time":"2024-10-17T07:49:59Z","timestamp":1729151399000},"page":"1227-1238","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Lack of Concentration\u2010QTc Relationship and Cardiac Risk With Vatiquinone Therapeutic and Supratherapeutic Doses"],"prefix":"10.1002","volume":"13","author":[{"given":"Lucy","family":"Lee","sequence":"first","affiliation":[{"name":"PTC Therapeutics, Inc.  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