scholarly journals The Effects of a Meal on QTc to Demonstrate ECG Assay Sensitivity in Phase I Studies

2016 ◽  
Vol 08 (06) ◽  
Author(s):  
Jorg Taubel ◽  
Georg Ferber ◽  
Sara Fernandes ◽  
Ulrike Lorch ◽  
Mariano Sust ◽  
...  
Keyword(s):  
Phase I ◽  
Assay Sensitivity ◽  
Phase I Studies

scholarly journals The Power of Phase I Studies to Detect Clinical Relevant QTc Prolongation: A Resampling Simulation Study

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Georg Ferber ◽  
Ulrike Lorch ◽  
Jörg Täubel
Keyword(s):  
Phase I ◽  
Healthy Subjects ◽  
Sparse Sampling ◽  
Positive Control ◽  
Qtc Prolongation ◽  
False Negatives ◽  
Assay Sensitivity ◽  
Phase I Studies ◽  
Sufficient Power

Concentration-effect (CE) models applied to early clinical QT data from healthy subjects are described in the latest E14 Q&A document as promising analysis to characterise QTc prolongation. The challenges faced if one attempts to replace a TQT study by thorough ECG assessments in Phase I based on CE models are the assurance to obtain sufficient power and the establishment of a substitute for the positive control to show assay sensitivity providing protection against false negatives. To demonstrate that CE models in small studies can reliably predict the absence of an effect on QTc, we investigated the role of some key design features in the power of the analysis. Specifically, the form of the CE model, inclusion of subjects on placebo, and sparse sampling on the performance and power of this analysis were investigated. In this study, the simulations conducted by subsampling subjects from 3 different TQT studies showed that CE model with a treatment effect can be used to exclude small QTc effects. The number of placebo subjects was also shown to increase the power to detect an inactive drug preventing false positives while an effect can be underestimated if time points aroundtmaxare missed.

scholarly journals Romidepsin and lenalidomide based regimens have efficacy in relapsed/refractory lymphoma: combined analysis of two phase I studies with expansion cohorts

2021 ◽  
Author(s):  
Neha Mehta‐Shah ◽  
Matthew A. Lunning ◽  
Alison J. Moskowitz ◽  
Adam M. Boruchov ◽  
Jia Ruan ◽  
...  
Keyword(s):  
Phase I ◽  
Two Phase ◽  
Phase I Studies ◽  
Combined Analysis ◽  
Refractory Lymphoma

scholarly journals Relative Bioavailability of Orally Dispersible Tablet Formulations of Levo‐ and Racemic Praziquantel: Two Phase I Studies

2018 ◽  
Vol 12 (1) ◽  
pp. 66-76 ◽  
Author(s):  
Wilhelmina Maria Bagchus ◽  
Deon Bezuidenhout ◽  
Eleanor Harrison‐Moench ◽  
Elly Kourany‐Lefoll ◽  
Peter Wolna ◽  
...  
Keyword(s):  
Phase I ◽  
Relative Bioavailability ◽  
Two Phase ◽  
Phase I Studies ◽  
Dispersible Tablet ◽  
Tablet Formulations

scholarly journals C-Met targeted fluorescence molecular endoscopy in Barrett's esophagus patients and identification of outcome parameters for phase-I studies

Theranostics ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. 5357-5367
Author(s):  
Steven J. de Jongh ◽  
Floris J. Voskuil ◽  
Iris Schmidt ◽  
Arend Karrenbeld ◽  
Gursah Kats-Ugurlu ◽  
...  
Keyword(s):  
Phase I ◽  
Barrett’S Esophagus ◽  
Barrett's Esophagus ◽  
Phase I Studies ◽  
Outcome Parameters

scholarly journals Phase i studies with baker's antifol (baf) (nsc 139105)

Cancer ◽  
1976 ◽  
Vol 38 (2) ◽  
pp. 690-694 ◽  
Author(s):  
Victorio Rodriguez ◽  
Jeffrey Gottlieb ◽  
Michael A. Burgess ◽  
Robert Livingston ◽  
Warren Wheeler ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Studies
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