Randomized, Blinded, Placebo- and Positive-Controlled Crossover Study to Determine the Effect of Deferiprone on the QTc Interval in Healthy Subjects

2017 ◽  
Vol 7 (1) ◽  
pp. 22-32 ◽  
Author(s):  
Caroline Fradette ◽  
Anna Rozova ◽  
Anne Stilman ◽  
Yu Chung Tsang ◽  
Mark J. Allison ◽  
...  
Keyword(s):  
Crossover Study ◽  
Healthy Subjects ◽  
Qtc Interval

scholarly journals Diurnal Corrected QT Interval and QT Dispersion Variation in Non-Alcoholic Cirrhotic Patients and Healthy Control: A Case-Control Study, Iran

2020 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Taghi Amiriani ◽  
Vahid Khori ◽  
Ali Davarian ◽  
Niloofar Rajabli ◽  
Mahsa Niknam ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Diurnal Variation ◽  
Healthy Subjects ◽  
Alcoholic Cirrhosis ◽  
Qt Dispersion ◽  
Qtc Interval ◽  
Healthy Controls ◽  
Cirrhotic Patients ◽  
The Mean

Background: Cirrhosis could lead to a long corrected QT (QTc) interval in a subgroup of patients, but there are spare data on its diurnal variation. Objectives: The present study aimed to determine the diurnal variation of QTc interval and its relationship to heart rate and blood pressure variation during 24-hour Holter-monitoring in non-alcoholic cirrhosis in comparison with the healthy controls. Methods: The study population comprised 15 patients with non-alcoholic cirrhosis and 15 healthy subjects, undergoing 24-hour electrocardiogram (ECG), heart rate, and blood pressure monitoring. The mean QT interval, mean QTc, maximum and minimum QT, QT dispersion (QT disp), heart rate, and mean arterial blood pressure were measured for each person for 24 hours. Liver stiffness measurement (LSM) was performed by FibroScan® 502 machine (EchoSense, Paris, France, 5 MHz). The results were demonstrated as percentages and mean ± SD. P value ≤ 0.05 was considered significant. Results: Mean QTc was significantly higher in cirrhosis (438 ms) than healthy controls (401.7 ms) (P = 0.03). The mean heart rate was significantly different in cirrhotic patients (79.6 ± 2.9/bpm) compared to healthy controls (72.47 ± 2.0/bpm) (P = 0.05). Conclusions: In this study, QTc was prolonged and increased with the severity of cirrhosis, and its diurnal variation in cirrhosis was different from healthy subjects.

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.

Single-Dose Comparative Pharmacokinetics of Two Formulations of Lenalidomide 25 mg in Healthy Subjects: A Randomized Crossover Study

2018 ◽  
Vol 35 (2) ◽  
pp. 210-217
Author(s):  
SeungHwan Lee ◽  
Jun Gi Hwang ◽  
Sang Yeob Park ◽  
Hye Jung Lim ◽  
Sa-Won Lee ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Healthy Subjects ◽  
Randomized Crossover Study

scholarly journals Randomized study of the effect of gadopiclenol, a new gadolinium‐based contrast agent, on the QTc interval in healthy subjects

2020 ◽  
Vol 86 (11) ◽  
pp. 2174-2181
Author(s):  
Christian Funck‐Brentano ◽  
Mathieu Felices ◽  
Nathalie Le Fur ◽  
Corinne Dubourdieu ◽  
Pierre Desché ◽  
...  
Keyword(s):  
Contrast Agent ◽  
Healthy Subjects ◽  
Randomized Study ◽  
Qtc Interval

P2-508: No Clinically Relevant Effect of BMS-708163, a γ-Secretase Inhibitor, on QTc Interval in Healthy Subjects

2011 ◽  
Vol 7 ◽  
pp. S475-S475
Author(s):  
Gary Tong ◽  
Oleksandr Sverdlov ◽  
Wai Chan ◽  
Matthew Cahir ◽  
Jun-Sheng Wang ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Qtc Interval ◽  
Relevant Effect ◽  
Secretase Inhibitor

Ibuprofen: Plasma Concentrations in Man

1985 ◽  
Vol 13 (1) ◽  
pp. 68-73 ◽  
Author(s):  
G M E Janssen ◽  
J F Venema
Keyword(s):  
Side Effects ◽  
Crossover Study ◽  
Plasma Levels ◽  
Healthy Subjects ◽  
Peak Plasma ◽  
Plasma Concentrations ◽  
Repeated Dose ◽  
Similar Range ◽  
The Mean ◽  
Peak Value

The plasma levels of Ibuprofen were measured in five healthy subjects who took 600 mg tablets of Ibuprofen twice daily, three times daily and four times daily in a crossover study. Peak plasma levels were obtained 1 hour after the first dose in all but one subject (slow absorber), the mean peak value being 51·3 μg.ml−1 (range 39·4–63·7 μg.ml−1). After the repeated dose regimens of two, three or four times daily of ibuprofen, the peak levels achieved were in a similar range to those seen after the first dose: Twice daily 39·4–66·4 μg.ml−1 Three times daily 43·6–63·3 μg.ml−1 Four times daily 44·1–58·4 μg.ml−1 There was no evidence of accumulation of the drug and no side-effects occurred during the trial.

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