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

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

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 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

scholarly journals Correction to: Ibrutinib does not prolong the corrected QT interval in healthy subjects: results from a thorough QT study

2017 ◽  
Vol 81 (2) ◽  
pp. 423-423
Author(s):  
Jan de Jong ◽  
Peter Hellemans ◽  
James Juhui Jiao ◽  
Yuhan Huang ◽  
Sofie Mesens ◽  
...  
Keyword(s):  
Qt Interval ◽  
Healthy Subjects ◽  
Corrected Qt Interval ◽  
Thorough Qt Study
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