scholarly journals Phase I studies of the safety, tolerability, pharmacokinetics, and pharmacodynamics of DS‐1211, a tissue‐nonspecific alkaline phosphatase inhibitor

2022 ◽  
Author(s):  
Sonomi Maruyama ◽  
Hester Visser ◽  
Takashi Ito ◽  
Tharin Limsakun ◽  
Hamim Zahir ◽  
...  
Keyword(s):  
Alkaline Phosphatase ◽  
Phase I ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Phase I Studies ◽  
Phosphatase Inhibitor ◽  
Tissue Nonspecific Alkaline Phosphatase

Phase I studies on the safety, tolerability, pharmacokinetics and pharmacodynamics of SB-649868, a novel dual orexin receptor antagonist

2011 ◽  
Vol 26 (8) ◽  
pp. 1058-1070 ◽  
Author(s):  
Paolo Bettica ◽  
Gianluca Nucci ◽  
Caroline Pyke ◽  
Lisa Squassante ◽  
Stefano Zamuner ◽  
...  
Keyword(s):  
Phase I ◽  
Receptor Antagonist ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Phase I Studies

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 FrancisellaDnaK Inhibits Tissue-nonspecific Alkaline Phosphatase

2012 ◽  
Vol 287 (44) ◽  
pp. 37185-37194 ◽  
Author(s):  
Bernard P. Arulanandam ◽  
Senthilnath Lakshmana Chetty ◽  
Jieh-Juen Yu ◽  
Sean Leonard ◽  
Karl Klose ◽  
...  
Keyword(s):  
Alkaline Phosphatase ◽  
Tissue Nonspecific Alkaline Phosphatase

scholarly journals Pharmacokinetics and Pharmacodynamics of Itepekimab in Healthy Adults and Patients With Asthma: Phase I First‐in‐Human and First‐in‐Patient Trials

2021 ◽  
Author(s):  
Matthew P. Kosloski ◽  
George D. Kalliolias ◽  
Christine R. Xu ◽  
Sivan Harel ◽  
Ching‐Ha Lai ◽  
...  
Keyword(s):  
Phase I ◽  
Healthy Adults ◽  
Pharmacokinetics And Pharmacodynamics

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.

Gingival Crevicular Fluid Alkaline Phosphatase Levels in Postmenopausal Women: Effects of Phase I Periodontal Treatment

2006 ◽  
Vol 77 (1) ◽  
pp. 67-72 ◽  
Author(s):  
Özlem Daltaban ◽  
Işıl Saygun ◽  
Belgin Bal ◽  
Köksal Baloş ◽  
Muhittin Serdar
Keyword(s):  
Alkaline Phosphatase ◽  
Phase I ◽  
Postmenopausal Women ◽  
Gingival Crevicular Fluid ◽  
Periodontal Treatment ◽  
Crevicular Fluid
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