P3-283: Pharmacokinetics, pharmacodynamics, and safety of the novel bace inhibitor bi1181181 after oral administration of single ascending doses in healthy subjects

2015 ◽  
Vol 11 (7S_Part_16) ◽  
pp. P740-P741 ◽  
Author(s):  
Laurent Nicolas ◽  
Klaus-Peter Kammerer ◽  
Jennifer Schaible ◽  
Jasmin Link ◽  
Oliver Kleiner ◽  
...  
Keyword(s):  
Oral Administration ◽  
Healthy Subjects ◽  
The Novel ◽  
Bace Inhibitor

P1-221: Safety and pharmacokinetics of the novel BACE inhibitor MK-8931 in healthy subjects following single- and Multiple-Dose administration

2012 ◽  
Vol 8 (4S_Part_5) ◽  
pp. P184-P185 ◽  
Author(s):  
Jack Tseng ◽  
Marissa Dockendorf ◽  
Gopal Krishna ◽  
Lei Ma ◽  
John Palcza ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Multiple Dose ◽  
The Novel ◽  
Dose Administration ◽  
Multiple Dose Administration ◽  
Bace Inhibitor

P3-282: Single oral doses of the novel bace inhibitor bi 1181181 significantly reduce concentrations of cerebrospinal fluid amyloid-beta peptides in healthy subjects

2015 ◽  
Vol 11 (7S_Part_16) ◽  
pp. P740-P740 ◽  
Author(s):  
Andreas Borta ◽  
Laurent Nicolas ◽  
Oliver Kleiner ◽  
Klaus-Peter Kammerer ◽  
Jennifer Schaible ◽  
...  
Keyword(s):  
Cerebrospinal Fluid ◽  
Amyloid Beta ◽  
Healthy Subjects ◽  
The Novel ◽  
Amyloid Beta Peptides ◽  
Beta Peptides ◽  
Bace Inhibitor ◽  
Oral Doses

The Novel BACE Inhibitor MK-8931 Dramatically Lowers CSF A  Peptides in Healthy Subjects: Results from a Rising Single Dose Study (PL02.004)

Neurology ◽  
2012 ◽  
Vol 78 (Meeting Abstracts 1) ◽  
pp. PL02.004-PL02.004 ◽  
Author(s):  
M. Forman ◽  
J. Tseng ◽  
J. Palcza ◽  
J. Leempoels ◽  
S. Ramael ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
The Novel ◽  
Single Dose Study ◽  
Bace Inhibitor ◽  
Dose Study

scholarly journals Importance of between and within Subject Variability in Extracellular Vesicle Abundance and Cargo when Performing Biomarker Analyses

Cells ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 485
Author(s):  
Lauren A. Newman ◽  
Alia Fahmy ◽  
Michael J. Sorich ◽  
Oliver G. Best ◽  
Andrew Rowland ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Drug Exposure ◽  
Extracellular Vesicle ◽  
The Novel ◽  
Protein Markers ◽  
Diurnal Variability ◽  
Normal Ranges ◽  
Sampling Protocols ◽  
Subject Variability ◽  
Within Subject Variability

Small extracellular vesicles (sEV) have emerged as a potential rich source of biomarkers in human blood and present the intriguing potential for a ‘liquid biopsy’ to track disease and the effectiveness of interventions. Recently, we have further demonstrated the potential for EV derived biomarkers to account for variability in drug exposure. This study sought to evaluate the variability in abundance and cargo of global and liver-specific circulating sEV, within (diurnal) and between individuals in a cohort of healthy subjects (n = 10). We present normal ranges for EV concentration and size and expression of generic EV protein markers and the liver-specific asialoglycoprotein receptor 1 (ASGR1) in samples collected in the morning and afternoon. EV abundance and cargo was generally not affected by fasting, except CD9 which exhibited a statistically significant increase (p = 0.018). Diurnal variability was observed in the expression of CD81 and ASGR1, which significantly decreased (p = 0.011) and increased (p = 0.009), respectively. These results have potential implications for study sampling protocols and normalisation of biomarker data when considering the expression of sEV derived cargo as a biomarker strategy. Specifically, the novel finding that liver-specific EVs exhibit diurnal variability in healthy subjects should have broad implications in the study of drug metabolism and development of minimally invasive biomarkers for liver disease.

P3-363: BACE inhibitor LY2886721 safety and central and peripheral PK and PD in healthy subjects (HSs)

2012 ◽  
Vol 8 (4S_Part_16) ◽  
pp. P583-P584 ◽  
Author(s):  
Ferenc Martenyi ◽  
Robert A. Dean ◽  
Stephen Lowe ◽  
Masako Nakano ◽  
Scott Monk ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Bace Inhibitor

Lack of influence of the antidopaminergic drug domperidone on basal and TRH-stimulated TSH-serum levels after oral administration

1982 ◽  
Vol 101 (4) ◽  
pp. 550-554 ◽  
Author(s):  
K. W. Wenzel ◽  
J. Döring
Keyword(s):  
Oral Administration ◽  
Thyroid Function ◽  
Oral Absorption ◽  
Statistical Significance ◽  
Oral Intake ◽  
Serum Levels ◽  
The Novel ◽  
Antiemetic Drug ◽  
First Pass ◽  
The Difference

Abstract. Since antidopaminergic drugs are known to elevate basal and TRH-stimulated TSH-serum levels and since this effect was also shown after iv administration of the novel dopamine antagonistic agent domperidone, it was investigated, whether this antiemetic drug could interfere after oral intake with the evaluation of thyroid function. Oral domperidone caused a marked TSH-enhancement of TRH-induced TSH increments in 6 out of 14 euthyroid subjects, with no statistical significance, however. The difference between oral and parenteral influence as well as inter-individual changes are probably due to the varying first pass effect of the drug after oral absorption.

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