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 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

A Thorough QT Study of the Combination Glecaprevir + Pibrentasvir on Cardiac Repolarization in Healthy Subjects

2020 ◽  
Vol 42 (7) ◽  
pp. 1317-1329
Author(s):  
Rajneet K. Oberoi ◽  
Weihan Zhao ◽  
Matthew Rosebraugh ◽  
Federico Mensa ◽  
Haoyu Wang ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Cardiac Repolarization ◽  
Thorough Qt Study

Evaluation of the Effect of Arbaclofen Placarbil, a Novel Transported Prodrug of R-Baclofen, on Cardiac Repolarization in a Thorough QT Study in Healthy Subjects

2009 ◽  
Vol 104 ◽  
pp. S17-S18
Author(s):  
Dan Chen ◽  
Ritu Lal ◽  
Jacob F. Huff ◽  
Juthamas Sukbuntherng ◽  
Wendy Luo ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Cardiac Repolarization ◽  
Thorough Qt Study

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

A thorough QT study to evaluate the effects of singledose exenatide 10 μg on cardiac repolarization in healthy subjects

2011 ◽  
Vol 49 (10) ◽  
pp. 594-604 ◽  
Author(s):  
H. Linnebjerg ◽  
M. Seger ◽  
P.A. Kothare ◽  
T. Hunt ◽  
A.M. Wolka ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Cardiac Repolarization ◽  
Thorough Qt Study

Thorough QT Study to Evaluate the Effect of Zoliflodacin, a Novel Therapeutic for Gonorrhea, on Cardiac Repolarization in Healthy Adults

2021 ◽  
Author(s):  
Lori M. Newman ◽  
Martin Kankam ◽  
Aya Nakamura ◽  
Tom Conrad ◽  
John Mueller ◽  
...  
Keyword(s):  
Oral Dose ◽  
Single Oral Dose ◽  
Cardiac Repolarization ◽  
Cardiac Safety ◽  
Double Blind ◽  
Thorough Qt Study ◽  
Regulatory Guidelines ◽  
Clinically Significant ◽  
The One ◽  
Global Threat

Zoliflodacin is a novel spiropyrimidinetrione antibiotic being developed as single oral dose treatment to address the growing global threat of Neisseria gonorrhoeae . To evaluate the cardiac safety of zoliflodacin, a thorough QT/QTc (TQT) study was performed in healthy subjects. In this randomized, double-blind, placebo-controlled, 4-period crossover study, 72 subjects in a fasted state received a single dose of zoliflodacin 2 g (therapeutic), zoliflodacin 4 g (supratherapeutic), placebo, and moxifloxacin 400 mg as a positive comparator. Cardiac repolarization was measured by duration of the corrected QT interval by Fridericia’s formula (QTcF). At each time point up to 24 hours after zoliflodacin administration, the upper limit of the one-sided 95% confidence interval (CI) for the placebo-corrected change from the pre-dose baseline in QTcF (ΔΔQTcF) was less than 10 ms, indicating an absence of a clinically meaningful increase in QT prolongation. The lower limit of the one-sided multiplicity-adjusted 95% CI of ΔΔQTcF for moxifloxacin was longer than 5 ms at four time points from 1-4 hours after dosing, demonstrating adequate sensitivity of the QTc measurement. There were no clinically significant effects on heart rate, PR and QRS intervals, ECG morphology, or laboratory values. Treatment-emergent adverse events (AEs) were mild or moderate in severity and transient. This was a negative TQT study according to regulatory guidelines (E14) and confirms that a single oral dose of zoliflodacin is safe and well-tolerated. These findings suggest zoliflodacin is not proarrhythmic and contribute to the favorable assessment of cardiac safety for a single oral dose of zoliflodacin.

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 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 No QTc Prolongation With Zanubrutinib: Results of Concentration‐QTc Analysis From a Thorough QT Study in Healthy Subjects

2020 ◽  
Author(s):  
Song Mu ◽  
Borje Darpo ◽  
Zhiyu Tang ◽  
William Novotny ◽  
Manal Tawashi ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Qtc Prolongation ◽  
Thorough Qt Study
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