scholarly journals Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PF-06751979, a Potent and Selective Oral BACE1 Inhibitor: Results from Phase I Studies in Healthy Adults and Healthy Older Subjects

2019 ◽  
Vol 71 (2) ◽  
pp. 581-595 ◽  
Author(s):  
Ruolun Qiu ◽  
Jae Eun Ahn ◽  
Robert Alexander ◽  
Michael A. Brodney ◽  
Ping He ◽  
...  
Keyword(s):  
Phase I ◽  
Healthy Adults ◽  
Phase I Studies ◽  
Bace1 Inhibitor ◽  
Pharmacodynamic Effects ◽  
Older Subjects

scholarly journals Pharmacokinetic and Pharmacodynamic Effects of a γ‐Secretase Modulator, PF ‐06648671, on CSF Amyloid‐β Peptides in Randomized Phase I Studies

2019 ◽  
Vol 107 (1) ◽  
pp. 211-220 ◽  
Author(s):  
Jae Eun Ahn ◽  
Charles Carrieri ◽  
Fernando Dela Cruz ◽  
Terence Fullerton ◽  
Eva Hajos‐Korcsok ◽  
...  
Keyword(s):  
Phase I ◽  
Amyloid Β ◽  
Phase I Studies ◽  
Pharmacodynamic Effects

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 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 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
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