scholarly journals A phase I, single and continuous dose administration study on the safety, tolerability, and pharmacokinetics of neorudin, a novel recombinant anticoagulant protein, in healthy subjects

2021 ◽  
Vol 9 (3) ◽  
Author(s):  
Yubin Liu ◽  
Meixia Wang ◽  
Xiaona Dong ◽  
Jia He ◽  
Lin Zhang ◽  
...  
Keyword(s):  
Phase I ◽  
Healthy Subjects ◽  
Dose Administration ◽  
Continuous Dose

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 Opicapone: a short lived and very long acting novel catechol-O-methyltransferase inhibitor following multiple dose administration in healthy subjects

2013 ◽  
Vol 76 (5) ◽  
pp. 763-775 ◽  
Author(s):  
José Francisco Rocha ◽  
Luis Almeida ◽  
Amílcar Falcão ◽  
P. Nuno Palma ◽  
Ana I. Loureiro ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Multiple Dose ◽  
Dose Administration ◽  
Multiple Dose Administration ◽  
Long Acting

scholarly journals BCX7353, a Potent Inhibitor of Plasma Kallikrein, Shows Sustained Maximal Enzyme Inhibition When Dosed Orally Once Daily: Results from a Phase I Trial in Healthy Subjects

2016 ◽  
Vol 137 (2) ◽  
pp. AB401 ◽  
Author(s):  
Melanie Cornpropst ◽  
Sylvia Dobo ◽  
Jo Collier ◽  
Angela Rose ◽  
Ramanda Wilson ◽  
...  
Keyword(s):  
Phase I ◽  
Enzyme Inhibition ◽  
Healthy Subjects ◽  
Phase I Trial ◽  
Potent Inhibitor ◽  
Plasma Kallikrein ◽  
Once Daily

scholarly journals First-in-human safety, tolerability, and pharmacokinetics of ammoxetine in healthy subjects: a randomized, double-blind, placebo-controlled phase I study

2021 ◽  
Vol 159 ◽  
pp. 105724
Author(s):  
Qi Shen ◽  
Chao Hu ◽  
Jia Miao ◽  
Junxia Chen ◽  
Yueying Peng ◽  
...  
Keyword(s):  
Phase I ◽  
Healthy Subjects ◽  
Phase I Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Human Safety

P1-229: Population pharmacokinetic modeling of the novel BACE inhibitor MK-8931 following single and multiple dose administration in healthy subjects

2012 ◽  
Vol 8 (4S_Part_5) ◽  
pp. P187-P187
Author(s):  
Lei Ma ◽  
Marissa Dockendorf ◽  
Gopal Krishna ◽  
Huub-Jan Kleijn ◽  
Jing Su ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Multiple Dose ◽  
Pharmacokinetic Modeling ◽  
Population Pharmacokinetic ◽  
The Novel ◽  
Dose Administration ◽  
Population Pharmacokinetic Modeling ◽  
Multiple Dose Administration ◽  
Bace Inhibitor

scholarly journals P679 Development of a novel auto-injector of subcutaneous CT-P13 infliximab: Phase I randomised, open-label, single-dose trial to compare the pharmacokinetics and safety to pre-filled syringe in healthy subjects

2019 ◽  
Vol 13 (Supplement_1) ◽  
pp. S458-S459
Author(s):  
S Schreiber ◽  
S Ben-Horin ◽  
B D Ye ◽  
R Westhovens ◽  
D H Yoo ◽  
...  
Keyword(s):  
Single Dose ◽  
Phase I ◽  
Healthy Subjects ◽  
Open Label ◽  
Dose Trial ◽  
Auto Injector

Effect of moderate activity on liver function and serum lipid level in healthy subjects during the phase I clinical trial

2020 ◽  
Vol 16 (12) ◽  
pp. 1217-1221
Author(s):  
Hong Zhang ◽  
Ting Liu ◽  
Cuiyun Li ◽  
Xiaojiao Li ◽  
Yanhua Ding
Keyword(s):  
Clinical Trial ◽  
Liver Function ◽  
Phase I ◽  
Healthy Subjects ◽  
Serum Lipid ◽  
Lipid Level ◽  
Serum Lipid Level ◽  
Phase I Clinical Trial ◽  
Moderate Activity

scholarly journals Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase I, Healthy Subjects Study of Intravenous OPN-305, a Humanized Anti-TLR2 Antibody

2013 ◽  
Vol 94 (5) ◽  
pp. 593-600 ◽  
Author(s):  
M Reilly ◽  
R M Miller ◽  
M H Thomson ◽  
V Patris ◽  
P Ryle ◽  
...  
Keyword(s):  
Phase I ◽  
Healthy Subjects ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Dose Escalating
Sign in / Sign up

Export Citation Format

Share Document