Lack of an Effect of Supratherapeutic Dose of Venlafaxine on Cardiac Repolarization in Healthy Subjects

2021 ◽  
Author(s):  
Richat Abbas ◽  
Steve Riley ◽  
Sunil Nepal ◽  
Mary Bachinsky ◽  
Kimberly C. Lee ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Cardiac Repolarization ◽  
Supratherapeutic Dose

scholarly journals A Thorough QT Study to Evaluate the Effects of a Supratherapeutic Dose of Sertraline on Cardiac Repolarization in Healthy Subjects

2020 ◽  
Vol 9 (3) ◽  
pp. 307-320
Author(s):  
Richat Abbas ◽  
Steve Riley ◽  
Robert R. LaBadie ◽  
Mary Bachinsky ◽  
Phillip B. Chappell ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Cardiac Repolarization ◽  
Supratherapeutic Dose ◽  
Thorough Qt Study

scholarly journals Supratherapeutic dose evaluation and effect of lesinurad on cardiac repolarization: a thorough QT/QTc study

2016 ◽  
Vol Volume 10 ◽  
pp. 3509-3517 ◽  
Author(s):  
Zancong Shen ◽  
Michael Gillen ◽  
Kathy Tieu ◽  
Mai Nguyen ◽  
Erin Harmon ◽  
...  
Keyword(s):  
Cardiac Repolarization ◽  
Dose Evaluation ◽  
Supratherapeutic Dose

scholarly journals A thorough QT study to assess the effects of tbo-filgrastim on cardiac repolarization in healthy subjects

2015 ◽  
pp. 2653 ◽  
Author(s):  
Liat Adar ◽  
Noa Avisar ◽  
Andreas Lammerich ◽  
Robert B. Kleiman ◽  
Ofer Spiegelstein
Keyword(s):  
Healthy Subjects ◽  
Cardiac Repolarization ◽  
Thorough Qt Study

scholarly journals No Effect of a Single Supratherapeutic Dose of Lersivirine, a Next-Generation Nonnucleoside Reverse Transcriptase Inhibitor, on Corrected QT Interval in Healthy Subjects

2012 ◽  
Vol 56 (5) ◽  
pp. 2408-2413 ◽  
Author(s):  
Manoli Vourvahis ◽  
Rong Wang ◽  
Marie-Noella Ndongo ◽  
Melissa O'Gorman ◽  
Margaret Tawadrous
Keyword(s):  
Upper Bound ◽  
Healthy Subjects ◽  
Vital Signs ◽  
Transcriptase Inhibitor ◽  
Qtc Interval ◽  
Adult Males ◽  
Supratherapeutic Dose ◽  
Nonnucleoside Reverse Transcriptase Inhibitor ◽  
Clinically Significant ◽  
Mean Differences

ABSTRACTThe objective of this study was to investigate the effect of a supratherapeutic dose of lersivirine (LRV) on corrected QT (QTc) interval using Fridericia's equation (QTcF) in healthy subjects. In this randomized, single-dose, placebo- and active-controlled 3-way crossover study, healthy adult males (n= 48) were randomized to receive LRV (2,400 mg), moxifloxacin (400 mg), or placebo for each treatment period. Triplicate 12-lead electrocardiogram measurements were performed, PK samples were collected, and vital signs were measured. Adverse event monitoring and safety laboratory testing were performed. All subjects were white (mean age, 39 years; body mass index [BMI], 25.6 kg/m2) and completed the study. Following LRV administration, the upper bound of the 90% confidence interval (CI) for time-matched adjusted mean differences to placebo QTcF at each time point postdose was below the regulatory threshold of 10 ms, satisfying the criteria for a negative thorough QT/QTc study. The highest upper bound of QTcF 90% CI occurred at 6 h for LRV (3.32 ms; 90% CI, 1.47 to 5.17 ms). The study was deemed adequately sensitive as the lower bound of the 90% CI for the adjusted mean QTcF differences between moxifloxacin and placebo at the moxifloxacin historicalTmaxof 3 h was >5 ms (15.29 ms; 90% CI, 13.44 to 17.14 ms). There was no statistically significant relationship between LRV exposure and placebo-adjusted change from baseline QTcF or clinically significant changes in QRS complex, pulse rate (PR) interval, heart rate, or blood pressure. LRV (2,400 mg) did not prolong the QTcF interval, and no clinically relevant electrocardiogram or vital sign changes were observed in healthy subjects.

scholarly journals Effect of Cabotegravir on Cardiac Repolarization in Healthy Subjects

2016 ◽  
Vol 5 (6) ◽  
pp. 509-516 ◽  
Author(s):  
Yu Lou ◽  
Ann M. Buchanan ◽  
Shuguang Chen ◽  
Susan L. Ford ◽  
Elizabeth Gould ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Cardiac Repolarization

Effects of Therapeutic and Supratherapeutic Doses of Siponimod (BAF312) on Cardiac Repolarization in Healthy Subjects

2015 ◽  
Vol 37 (11) ◽  
pp. 2489-2505.e2 ◽  
Author(s):  
Kasra Shakeri-Nejad ◽  
Vassilios Aslanis ◽  
Uday Kiran Veldandi ◽  
Louise Mooney ◽  
Nicole Pezous ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Cardiac Repolarization

scholarly journals Solithromycin, a novel macrolide, does not prolong cardiac repolarization: a randomized, three-way crossover study in healthy subjects

2016 ◽  
Vol 72 (2) ◽  
pp. 515-521 ◽  
Author(s):  
Borje Darpo ◽  
Philip T. Sager ◽  
Prabhavathi Fernandes ◽  
Brian D. Jamieson ◽  
Kara Keedy ◽  
...  
Keyword(s):  
Crossover Study ◽  
Healthy Subjects ◽  
Cardiac Repolarization

scholarly journals Eltrombopag does not affect cardiac repolarization: results from a definitive QTc study in healthy subjects

2010 ◽  
Vol 70 (1) ◽  
pp. 24-33 ◽  
Author(s):  
Gemma Matthys ◽  
Jung Wook Park ◽  
Sandra McGuire ◽  
Mary Beth Wire ◽  
Jianping Zhang ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Cardiac Repolarization

Evaluation of the effect of mericitabine at projected therapeutic and supratherapeutic doses on cardiac repolarization in healthy subjects: A thorough QT/QTc study

2014 ◽  
Vol 3 (3) ◽  
pp. 179-186
Author(s):  
Ya-Chi Chen ◽  
Joshua Haznedar ◽  
Rohit Kulkarni ◽  
Christelle Vistuer ◽  
Carla Washington ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Cardiac Repolarization

Effects of Prulifloxacin on Cardiac Repolarization in Healthy Subjects

2010 ◽  
Vol 30 (1) ◽  
pp. 5-14 ◽  
Author(s):  
Maria Teresa Rosignoli ◽  
Giorgio Di Loreto ◽  
Paolo Dionisio
Keyword(s):  
Healthy Subjects ◽  
Cardiac Repolarization
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