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Article ; Online: Caveolin-1 mediates blood-brain barrier permeability, neuroinflammation, and cognitive impairment in SARS-CoV-2 infection.

Trevino, Troy N / Almousawi, Ali A / Robinson, KaReisha F / Fogel, Avital B / Class, Jake / Minshall, Richard D / Tai, Leon M / Richner, Justin M / Lutz, Sarah E

Journal of neuroimmunology

2024 Volume 388, Page(s) 578309

Abstract: Blood-brain barrier (BBB) permeability can cause neuroinflammation and cognitive impairment. Caveolin-1 (Cav-1) critically regulates BBB permeability, but its influence on the BBB and consequent neurological outcomes in respiratory viral infections is ... ...

Abstract	Blood-brain barrier (BBB) permeability can cause neuroinflammation and cognitive impairment. Caveolin-1 (Cav-1) critically regulates BBB permeability, but its influence on the BBB and consequent neurological outcomes in respiratory viral infections is unknown. We used Cav-1-deficient mice with genetically encoded fluorescent endothelial tight junctions to determine how Cav-1 influences BBB permeability, neuroinflammation, and cognitive impairment following respiratory infection with mouse adapted (MA10) SARS-CoV-2 as a model for COVID-19. We found that SARS-CoV-2 infection increased brain endothelial Cav-1 and increased transcellular BBB permeability to albumin, decreased paracellular BBB Claudin-5 tight junctions, and caused T lymphocyte infiltration in the hippocampus, a region important for learning and memory. Concordantly, we observed learning and memory deficits in SARS-CoV-2 infected mice. Importantly, genetic deficiency in Cav-1 attenuated transcellular BBB permeability and paracellular BBB tight junction losses, T lymphocyte infiltration, and gliosis induced by SARS-CoV-2 infection. Moreover, Cav-1 KO mice were protected from the learning and memory deficits caused by SARS-CoV-2 infection. These results establish the contribution of Cav-1 to BBB permeability and behavioral dysfunction induced by SARS-CoV-2 neuroinflammation.
MeSH term(s)	Animals ; Mice ; Blood-Brain Barrier/metabolism ; Caveolin 1/genetics ; Caveolin 1/metabolism ; Cognitive Dysfunction/etiology ; COVID-19/complications ; Memory Disorders/etiology ; Neuroinflammatory Diseases ; Permeability ; SARS-CoV-2/metabolism
Chemical Substances	Caveolin 1 ; Cav1 protein, mouse
Language	English
Publishing date	2024-02-04
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	8335-5
ISSN	1872-8421 ; 0165-5728
ISSN (online)	1872-8421
ISSN	0165-5728
DOI	10.1016/j.jneuroim.2024.578309
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Article ; Online: Physiologically-Based Pharmacokinetic Modeling of Remdesivir and Its Metabolites to Support Dose Selection for the Treatment of Pediatric Patients With COVID-19.

Lutz, Justin D / Mathias, Anita / German, Polina / Pikora, Cheryl / Reddy, Sunila / Kirby, Brian J

Clinical pharmacology and therapeutics

2021 Volume 109, Issue 4, Page(s) 1116–1124

Abstract: Severe coronavirus disease 2019 (COVID-19) disease, including multisystem inflammatory syndrome, has been reported in children. This report summarizes development of a remdesivir physiologically-based pharmacokinetic (PBPK) model that accurately ... ...

Abstract	Severe coronavirus disease 2019 (COVID-19) disease, including multisystem inflammatory syndrome, has been reported in children. This report summarizes development of a remdesivir physiologically-based pharmacokinetic (PBPK) model that accurately describes observed adult remdesivir and metabolites exposure and predicts pediatric remdesivir and metabolites exposure. The adult PBPK model was applied to predict pediatric remdesivir and metabolites steady-state exposures using the Pediatric Population Model in SimCYP and incorporated the relevant physiologic and mechanistic information. Model development was based on adult phase I exposure data in healthy volunteers who were administered a 200-mg loading dose of remdesivir intravenous (IV) over 0.5 hours on Day 1, then 100-mg daily maintenance doses of IV over 0.5 hours starting on Day 2 and continuing through Days 5 or 10. Simulations indicated that use of the adult therapeutic remdesivir dosage regimen (200-mg loading dose on Day 1 then 100-mg daily maintenance dose starting on Day 2) in pediatric patients ≥ 40 kg and a weight-based remdesivir dosage regimen (5-mg/kg loading dose on Day 1 then 2.5-mg/kg daily maintenance dose starting on Day 2) in pediatric patients weighing 2.5 to < 40 kg is predicted to maintain therapeutic exposures of remdesivir and its metabolites. The comprehensive PBPK model described in this report supported remdesivir dosing in planned pediatric clinical studies and dosing in the emergency use authorization and pediatric compassionate use programs that were initiated to support remdesivir as a treatment option during the pandemic.
MeSH term(s)	Adenosine Monophosphate/administration & dosage ; Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/pharmacokinetics ; Adenosine Monophosphate/therapeutic use ; Adolescent ; Alanine/administration & dosage ; Alanine/analogs & derivatives ; Alanine/pharmacokinetics ; Alanine/therapeutic use ; Antiviral Agents/administration & dosage ; Antiviral Agents/pharmacokinetics ; Antiviral Agents/therapeutic use ; Area Under Curve ; Body Weight ; COVID-19/drug therapy ; Child ; Child, Preschool ; Computer Simulation ; Drug Dosage Calculations ; Female ; Humans ; Infant ; Male ; Models, Biological ; Pandemics ; SARS-CoV-2
Chemical Substances	Antiviral Agents ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2021-03-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.2176
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Article: The L1 cell adhesion molecule constrains dendritic spine density in pyramidal neurons of the mouse cerebral cortex.

Murphy, Kelsey E / Wade, Sarah D / Sperringer, Justin E / Mohan, Vishwa / Duncan, Bryce W / Zhang, Erin Y / Pak, Yubin / Lutz, David / Schachner, Melitta / Maness, Patricia F

Frontiers in neuroanatomy

2023 Volume 17, Page(s) 1111525

Abstract: A novel function for the L1 cell adhesion molecule, which binds the actin adaptor protein Ankyrin was identified in constraining dendritic spine density on pyramidal neurons in the mouse neocortex. In an L1-null mouse mutant increased spine density was ... ...

Abstract	A novel function for the L1 cell adhesion molecule, which binds the actin adaptor protein Ankyrin was identified in constraining dendritic spine density on pyramidal neurons in the mouse neocortex. In an L1-null mouse mutant increased spine density was observed on apical but not basal dendrites of pyramidal neurons in diverse cortical areas (prefrontal cortex layer 2/3, motor cortex layer 5, visual cortex layer 4. The Ankyrin binding motif (FIGQY) in the L1 cytoplasmic domain was critical for spine regulation, as demonstrated by increased spine density and altered spine morphology in the prefrontal cortex of a mouse knock-in mutant (L1YH) harboring a tyrosine (Y) to histidine (H) mutation in the FIGQY motif, which disrupted L1-Ankyrin association. This mutation is a known variant in the human L1 syndrome of intellectual disability. L1 was localized by immunofluorescence staining to spine heads and dendrites of cortical pyramidal neurons. L1 coimmunoprecipitated with Ankyrin B (220 kDa isoform) from lysates of wild type but not L1YH forebrain. This study provides insight into the molecular mechanism of spine regulation and underscores the potential for this adhesion molecule to regulate cognitive and other L1-related functions that are abnormal in the L1 syndrome.
Language	English
Publishing date	2023-03-16
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2452969-2
ISSN	1662-5129
ISSN	1662-5129
DOI	10.3389/fnana.2023.1111525
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Article ; Online: Corrigendum to 'Simpler and faster Covid-19 testing: Strategies to streamline SARS-CoV-2 molecular assays'.

Panpradist, Nuttada / Wang, Qin / Ruth, Parker S / Kotnik, Jack H / Oreskovic, Amy K / Miller, Abraham / Stewart, Samuel W A / Vrana, Justin / Han, Peter D / Beck, Ingrid A / Starita, Lea M / Frenkel, Lisa M / Lutz, Barry R

EBioMedicine

2021 Volume 66, Page(s) 103296

Language	English
Publishing date	2021-04-12
Publishing country	Netherlands
Document type	Published Erratum
ZDB-ID	2851331-9
ISSN	2352-3964
ISSN (online)	2352-3964
DOI	10.1016/j.ebiom.2021.103296
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Article ; Online: Pharmacokinetic, Pharmacodynamic, and Drug-Interaction Profile of Remdesivir, a SARS-CoV-2 Replication Inhibitor.

Humeniuk, Rita / Mathias, Anita / Kirby, Brian J / Lutz, Justin D / Cao, Huyen / Osinusi, Anu / Babusis, Darius / Porter, Danielle / Wei, Xuelian / Ling, John / Reddy, Y Sunila / German, Polina

Clinical pharmacokinetics

2021 Volume 60, Issue 5, Page(s) 569–583

Abstract: Remdesivir (RDV, ... ...

Abstract	Remdesivir (RDV, Veklury
MeSH term(s)	Adenosine/analogs & derivatives ; Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/pharmacokinetics ; Adenosine Monophosphate/pharmacology ; Adenosine Monophosphate/therapeutic use ; Adult ; Alanine/analogs & derivatives ; Alanine/pharmacokinetics ; Alanine/pharmacology ; Alanine/therapeutic use ; Animals ; Antiviral Agents/pharmacokinetics ; Antiviral Agents/pharmacology ; Area Under Curve ; COVID-19/drug therapy ; Dose-Response Relationship, Drug ; Drug Interactions ; Furans/metabolism ; Half-Life ; Humans ; Metabolic Clearance Rate ; Pyrroles/metabolism ; SARS-CoV-2 ; Triazines/metabolism
Chemical Substances	Antiviral Agents ; Furans ; Pyrroles ; Triazines ; GS-441524 (1BQK176DT6) ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Adenosine (K72T3FS567) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2021-03-30
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	197627-8
ISSN	1179-1926 ; 0312-5963
ISSN (online)	1179-1926
ISSN	0312-5963
DOI	10.1007/s40262-021-00984-5
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Zs.A 1246: Show issues

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Article ; Online: In vitro-to-in vivo predictions of drug-drug interactions involving multiple reversible inhibitors.

Lutz, Justin D / Isoherranen, Nina

Expert opinion on drug metabolism & toxicology

2012 Volume 8, Issue 4, Page(s) 449–466

Abstract: Introduction: Predictions of drug-drug interactions (DDIs) are commonly performed for single inhibitors, but interactions involving multiple inhibitors also frequently occur. Predictions of such interactions involving stereoisomer pairs, parent/ ... ...

Abstract	Introduction: Predictions of drug-drug interactions (DDIs) are commonly performed for single inhibitors, but interactions involving multiple inhibitors also frequently occur. Predictions of such interactions involving stereoisomer pairs, parent/metabolite combinations and simultaneously administered multiple inhibitors are increasing in importance. This review provides the framework for predicting inhibitory DDIs of multiple inhibitors with any combination of reversible inhibition mechanism. Areas covered: The review provides an overview of the reliability of the in vitro determined reversible inhibition mechanism. Furthermore, the article provides a method to predict DDIs for multiple reversible inhibitors that allows substituting the inhibition constant (K(i)) with an inhibitor affinity (IC(50)) value determined at S << K(M). Expert opinion: A better understanding and the prediction methods of DDIs, resulting from multiple inhibitors, are important. The inhibition mechanism of a reversible inhibitor is often equivocal across studies and unreliable. Determination of the K(i) requires the assignment of reversible inhibition mechanism but in vitro-to-in vivo prediction of DDI risk can be achieved for multiple inhibitors from estimates of the inhibitor affinity (IC(50)) only, regardless of the inhibition mechanism.
MeSH term(s)	Algorithms ; Animals ; Antidepressive Agents, Second-Generation/adverse effects ; Antidepressive Agents, Tricyclic/adverse effects ; Area Under Curve ; Cytochrome P-450 Enzyme Inhibitors ; Cytochrome P-450 Enzyme System/chemistry ; Desipramine/adverse effects ; Drug Interactions ; Drug-Related Side Effects and Adverse Reactions ; Enzyme Inhibitors/adverse effects ; Fluoxetine/adverse effects ; Forecasting ; Humans ; Kinetics ; Models, Statistical
Chemical Substances	Antidepressive Agents, Second-Generation ; Antidepressive Agents, Tricyclic ; Cytochrome P-450 Enzyme Inhibitors ; Enzyme Inhibitors ; Fluoxetine (01K63SUP8D) ; Cytochrome P-450 Enzyme System (9035-51-2) ; Desipramine (TG537D343B)
Language	English
Publishing date	2012-04
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2214462-6
ISSN	1744-7607 ; 1742-5255
ISSN (online)	1744-7607
ISSN	1742-5255
DOI	10.1517/17425255.2012.667801
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Zs.A 6264: Show issues

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Article ; Online: Implementation of an interactive mobile application to pilot a rapid assay to detect HIV drug resistance mutations in Kenya.

Vrana, Justin D / Panpradist, Nuttada / Higa, Nikki / Ko, Daisy / Ruth, Parker / Kanthula, Ruth / Lai, James J / Yang, Yaoyu / Sakr, Samar R / Chohan, Bhavna / Chung, Michael H / Frenkel, Lisa M / Lutz, Barry R / Klavins, Eric / Beck, Ingrid A

PLOS global public health

2022 Volume 2, Issue 2, Page(s) e0000185

Abstract: Usability is an overlooked aspect of implementing lab-based assays, particularly novel assays in low-resource-settings. Esoteric instructions can lead to irreproducible test results and patient harm. To address these issues, we developed a software ... ...

Abstract	Usability is an overlooked aspect of implementing lab-based assays, particularly novel assays in low-resource-settings. Esoteric instructions can lead to irreproducible test results and patient harm. To address these issues, we developed a software application based on "Aquarium", a laboratory-operating system run on a computer tablet that provides step-by-step digital interactive instructions, protocol management, and sample tracking. Aquarium was paired with a near point-of-care HIV drug resistance test, "OLA-Simple", that detects mutations associated with virologic failure. In this observational study we evaluated the performance of Aquarium in guiding untrained users through the multi-step laboratory protocol with little supervision. To evaluate the training by Aquarium software we conducted a feasibility study in a laboratory at Coptic Hope Center in Nairobi, Kenya. Twelve volunteers who were unfamiliar with the kit performed the test on blinded samples (2 blood specimens; 5 codons/sample). Steps guided by Aquarium included: CD4+ T-Cell separation, PCR, ligation, detection, and interpretation of test results. Participants filled out a short survey regarding their demographics and experience with the software and kit. None of the laboratory technicians had prior experience performing CD4+ separation and 7/12 had no experience performing laboratory-based molecular assays. 12/12 isolated CD4+ T cells from whole blood with yields comparable to isolations performed by trained personnel. The OLA-Simple workflow was completed by all, with genotyping results interpreted correctly by unaided-eye in 108/120 (90%) and by software in 116/120 (97%) of codons analyzed. In the surveys, participants favorably assessed the use of software guidance. The Aquarium digital instructions enabled first-time users in Kenya to complete the OLA-simple kit workflow with minimal training. Aquarium could increase the accessibility of laboratory assays in low-resource-settings and potentially standardize implementation of clinical laboratory tests.
Language	English
Publishing date	2022-02-16
Publishing country	United States
Document type	Journal Article
ISSN	2767-3375
ISSN (online)	2767-3375
DOI	10.1371/journal.pgph.0000185
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Article ; Online: Prediction of relative in vivo metabolite exposure from in vitro data using two model drugs: dextromethorphan and omeprazole.

Lutz, Justin D / Isoherranen, Nina

Drug metabolism and disposition: the biological fate of chemicals

2011 Volume 40, Issue 1, Page(s) 159–168

Abstract: Metabolites can have pharmacological or toxicological effects, inhibit metabolic enzymes, and be used as probes of drug-drug interactions or specific cytochrome P450 (P450) phenotypes. Thus, better understanding and prediction methods are needed to ... ...

Abstract	Metabolites can have pharmacological or toxicological effects, inhibit metabolic enzymes, and be used as probes of drug-drug interactions or specific cytochrome P450 (P450) phenotypes. Thus, better understanding and prediction methods are needed to characterize metabolite exposures in vivo. This study aimed to test whether in vitro data could be used to predict and rationalize in vivo metabolite exposures using two model drugs and P450 probes: dextromethorphan and omeprazole with their primary metabolites dextrorphan, 5-hydroxyomeprazole (5OH-omeprazole), and omeprazole sulfone. Relative metabolite exposures were predicted using metabolite formation and elimination clearances. For dextrorphan, the formation clearances of dextrorphan glucuronide and 3-hydroxymorphinan from dextrorphan in human liver microsomes were used to predict metabolite (dextrorphan) clearance. For 5OH-omeprazole and omeprazole sulfone, the depletion rates of the metabolites in human hepatocytes were used to predict metabolite clearance. Dextrorphan/dextromethorphan in vivo metabolite/parent area under the plasma concentration versus time curve ratio (AUC(m)/AUC(p)) was overpredicted by 2.1-fold, whereas 5OH-omeprazole/omeprazole and omeprazole sulfone/omeprazole were predicted within 0.75- and 1.1-fold, respectively. The effect of inhibition or induction of the metabolite's formation and elimination on the AUC(m)/AUC(p) ratio was simulated. The simulations showed that unless metabolite clearance pathways are characterized, interpretation of the metabolic ratios is exceedingly difficult. This study shows that relative in vivo metabolite exposure can be predicted from in vitro data and characterization of secondary metabolism of probe metabolites is critical for interpretation of phenotypic data.
MeSH term(s)	Dextromethorphan/chemistry ; Dextromethorphan/metabolism ; Humans ; Microsomes, Liver/enzymology ; Microsomes, Liver/metabolism ; Omeprazole/chemistry ; Omeprazole/metabolism ; Predictive Value of Tests
Chemical Substances	Dextromethorphan (7355X3ROTS) ; Omeprazole (KG60484QX9)
Language	English
Publishing date	2011-10-18
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	186795-7
ISSN	1521-009X ; 0090-9556
ISSN (online)	1521-009X
ISSN	0090-9556
DOI	10.1124/dmd.111.042200
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Zs.A 1014: Show issues

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Article ; Online: Corrigendum to ‘Simpler and faster Covid-19 testing

Nuttada Panpradist / Qin Wang / Parker S. Ruth / Jack H. Kotnik / Amy K. Oreskovic / Abraham Miller / Samuel W.A. Stewart / Justin Vrana / Peter D. Han / Ingrid A. Beck / Lea M. Starita / Lisa M. Frenkel / Barry R. Lutz

EBioMedicine, Vol 66, Iss , Pp 103296- (2021)

Strategies to streamline SARS-CoV-2 molecular assays’

2021

Keywords	Medicine ; R ; Medicine (General) ; R5-920
Language	English
Publishing date	2021-04-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Simpler and faster Covid-19 testing: Strategies to streamline SARS-CoV-2 molecular assays.

EBioMedicine

2021 Volume 64, Page(s) 103236

Abstract: Background: Detection of SARS-CoV-2 infections is important for treatment, isolation of infected and exposed individuals, and contact tracing. RT-qPCR is the "gold-standard" method to sensitively detect SARS-CoV-2 RNA, but most laboratory-developed RT- ... ...

Abstract	Background: Detection of SARS-CoV-2 infections is important for treatment, isolation of infected and exposed individuals, and contact tracing. RT-qPCR is the "gold-standard" method to sensitively detect SARS-CoV-2 RNA, but most laboratory-developed RT-qPCR assays involve complex steps. Here, we aimed to simplify RT-qPCR assays by streamlining reaction setup, eliminating RNA extraction, and proposing reduced-cost detection workflows that avoid the need for expensive qPCR instruments. Method: A low-cost RT-PCR based "kit" was developed for faster turnaround than the CDC developed protocol. We demonstrated three detection workflows: two that can be deployed in laboratories conducting assays of variable complexity, and one that could be simple enough for point-of-care. Analytical sensitivity was assessed using SARS-CoV-2 RNA spiked in simulated nasal matrix. Clinical performance was evaluated using contrived human nasal matrix (n = 41) and clinical nasal specimens collected from individuals with respiratory symptoms (n = 110). Finding: The analytical sensitivity of the lyophilised RT-PCR was 10 copies/reaction using purified SARS-CoV-2 RNA, and 20 copies/reaction when using direct lysate in simulated nasal matrix. Evaluation of assay performance on contrived human matrix showed 96.7-100% specificity and 100% sensitivity at ≥20 RNA copies. A head-to-head comparison with the standard CDC protocol on clinical specimens showed 83.8-94.6% sensitivity and 96.8-100% specificity. We found 3.6% indeterminate samples (undetected human control), lower than 8.1% with the standard protocol. Interpretation: This preliminary work should support laboratories or commercial entities to develop and expand access to Covid-19 testing. Software guidance development for this assay is ongoing to enable implementation in other settings. FUND: USA NIH R01AI140845 and Seattle Children's Research Institute.
MeSH term(s)	COVID-19/diagnosis ; COVID-19/genetics ; COVID-19 Nucleic Acid Testing ; Humans ; RNA, Viral/genetics ; Real-Time Polymerase Chain Reaction ; Reverse Transcriptase Polymerase Chain Reaction ; SARS-CoV-2/genetics ; Sensitivity and Specificity
Chemical Substances	RNA, Viral
Language	English
Publishing date	2021-02-12
Publishing country	Netherlands
Document type	Clinical Trial ; Journal Article ; Multicenter Study
ZDB-ID	2851331-9
ISSN	2352-3964
ISSN (online)	2352-3964
DOI	10.1016/j.ebiom.2021.103236
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