Ubrogepant is a novel, oral calcitonin gene-related peptide receptor antagonist currently under US Food and Drug Administration (FDA) review for the acute treatment of migraine attacks. This double-blind, four-period crossover study compared the cardiac repolarization effect of therapeutic (100 mg) and supratherapeutic (400 mg) ubrogepant doses vs. placebo in healthy adults. Moxifloxacin 400 mg was used as an open-label active control, and the primary end point was change from baseline in Fridericia-corrected QT intervals (ΔQTcF). Assay sensitivity was demonstrated via statistically significant QTcF prolongation with moxifloxacin vs. placebo. After single oral doses of ubrogepant, the least squares mean placebo-corrected ΔQTcF (ΔΔQTcF) and 90% confidence intervals (CIs) did not exceed the 10-millisecond regulatory threshold at any timepoint. The 90% CI upper bounds were 2.46 milliseconds and 2.69 milliseconds for ubrogepant 100 and 400 mg, respectively. Categorical and concentration-based analyses were consistent with the primary result, showing no significant impact of ubrogepant on cardiac repolarization.

中文翻译：

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Ubrogepant的单一治疗和治疗剂量不会影响健康成年人的心脏复极化：来自随机试验的结果。

Ubrogepant是一种新型的口服降钙素基因相关肽受体拮抗剂，目前正接受美国食品和药物管理局（FDA）的审查，用于偏头痛发作的急性治疗。这项双盲，四期交叉研究比较了健康成年人中治疗性剂量（100 mg）和超剂量治疗性药物（400 mg）与安慰剂的心脏复极效果。将400 mg莫西沙星用作开放标签的主动对照，主要终点是在Fridericia校正的QT间隔（ΔQTcF）中相对于基线的变化。通过莫西沙星与安慰剂的QTcF延长具有统计学意义，证明了测定的敏感性。口服单剂量的ubrogepant后，最小二乘均值的平均安慰剂校正后的ΔQTcF（ΔΔQTcF）和90％的置信区间（CIs）在任何时间点均不超过10毫秒的调节阈值。ubrogepant 100和400 mg的90％CI上限分别为2.46毫秒和2.69毫秒。分类和基于浓度的分析与主要结果一致，表明ubrogepant对心脏复极没有显着影响。