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Article ; Online: Impact of COVID-19 on the Conduct and Design of Clinical Trials: IQ Consortium Perspective.

Mohamed, Mohamed-Eslam F / Girish, Sandhya / Humeniuk, Rita / Nuthalapati, Silpa / Desai, Amit / Datta-Mannan, Amita / Gheyas, Ferdous / Kanodia, Jitendra / Cheeti, Sravanthi / Zhu, Tong

Clinical pharmacology and therapeutics

2024

Language	English
Publishing date	2024-03-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.3242
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Article ; Online: Reply to Yan and Muller, "Remdesivir for COVID-19: Why Not Dose Higher?"

Juneja, Kavita / Humeniuk, Rita / Porter, Danielle / Cao, Huyen / Feng, Joy

Antimicrobial agents and chemotherapy

2021 Volume 65, Issue 4

MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Alanine/analogs & derivatives ; COVID-19/drug therapy ; Humans ; SARS-CoV-2
Chemical Substances	remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2021-03-18
Publishing country	United States
Document type	Journal Article ; Comment
ZDB-ID	217602-6
ISSN	1098-6596 ; 0066-4804
ISSN (online)	1098-6596
ISSN	0066-4804
DOI	10.1128/AAC.00085-21
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Zs.A 809: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Remdesivir for COVID-19 in Hospitalized Children: A Phase 2/3 Study.

Ahmed, Amina / Munoz, Flor M / Muller, William J / Agwu, Allison / Kimberlin, David W / Galli, Luisa / Deville, Jaime G / Sue, Paul K / Mendez-Echevarria, Ana / Humeniuk, Rita / Guo, Susan / Rodriguez, Lauren / Han, Dong / Hedskog, Charlotte / Maxwell, Heather / Palaparthy, Ramesh / Kersey, Kathryn / Rojo, Pablo

Pediatrics

2024 Volume 153, Issue 3

Abstract: Objectives: Remdesivir decreases the risk of SARS-CoV-2 infection progressing to severe disease in adults. This study evaluated remdesivir safety and pharmacokinetics in infants and children.: Methods: This was a phase 2/3, open-label trial in ... ...

Abstract	Objectives: Remdesivir decreases the risk of SARS-CoV-2 infection progressing to severe disease in adults. This study evaluated remdesivir safety and pharmacokinetics in infants and children. Methods: This was a phase 2/3, open-label trial in children aged 28 days to 17 years hospitalized for polymerase chain reaction-confirmed SARS-CoV-2 infection. Participants received for ≤10 days once-daily intravenous remdesivir doses defined using physiologically based pharmacokinetic modeling (for ≥40 kg, 200 mg day 1, then 100 mg/day; for age ≥28 days and ≥3 to <40 kg, 5 mg/kg day 1, then 2.5 mg/kg/day). Sparse pharmacokinetic samples were analyzed using population-pharmacokinetic approaches for remdesivir and metabolites GS-704277 and GS-441524. Results: Among 53 participants, at enrollment the median (Q1, Q3) number of days of COVID-19 symptoms was 5 (3, 7) and hospitalization was 1 (1, 3). Underlying conditions included obesity in 19 (37%), asthma in 11 (21%), and cardiac disorders in 11 (21%). Median duration of remdesivir treatment was 5 days (range, 1-10). Remdesivir treatment had no new apparent safety trends. Two participants discontinued treatment because of adverse events including elevated transaminases; both had elevated transaminases at baseline. Three deaths occurred during treatment (and 1 after). When compared with phase 3 adult data, estimated mean pediatric parameters (area under the concentration-time curve over 1 dosing interval, AUCτ, Cmax, and Cτ) were largely overlapping but modestly increased (remdesivir, 33%-129%; GS-704277, 37%-124%; GS-441524, 0%-60%). Recovery occurred for 62% of participants on day 10 and 83% at last assessment. Conclusions: In infants and children with COVID-19, the doses of remdesivir evaluated provided drug exposure similar to adult dosing. In this study with a small sample size, no new safety concerns were observed.
MeSH term(s)	Adult ; Infant ; Humans ; Child ; Child, Hospitalized ; COVID-19 ; COVID-19 Drug Treatment ; SARS-CoV-2 ; Pyrroles ; Transaminases ; Adenosine Monophosphate/analogs & derivatives ; Alanine/analogs & derivatives
Chemical Substances	remdesivir (3QKI37EEHE) ; Pyrroles ; Transaminases (EC 2.6.1.-) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2024-03-04
Publishing country	United States
Document type	Clinical Trial, Phase III ; Clinical Trial, Phase II ; Journal Article
ZDB-ID	207677-9
ISSN	1098-4275 ; 0031-4005
ISSN (online)	1098-4275
ISSN	0031-4005
DOI	10.1542/peds.2023-063775
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Article ; Online: Plasma Protein Binding Determination for Unstable Ester Prodrugs: Remdesivir and Tenofovir Alafenamide.

Wen, Anita / Qin, Ann Ran-Ran / Tarnowski, Thomas / Ling, Kah Hiing John / Zhang, Haeyoung / Humeniuk, Rita / Regan, Sean / Saquing, Jovita / Liu, Wenbin / Venkatarangan, Lata / Xiao, Deqing

Journal of pharmaceutical sciences

2023 Volume 112, Issue 12, Page(s) 3224–3232

Abstract: Remdesivir (RDV) and tenofovir alafenamide (TAF) are prodrugs designed to be converted to their respective active metabolites. Plasma protein binding (PPB) determination of these prodrugs is important for patients with possible alteration of free ... ...

Abstract	Remdesivir (RDV) and tenofovir alafenamide (TAF) are prodrugs designed to be converted to their respective active metabolites. Plasma protein binding (PPB) determination of these prodrugs is important for patients with possible alteration of free fraction of the drugs due to plasma protein changes in renal impairment, hepatic impairment, or pregnancy. However, the prodrugs' instability in human plasma presents a challenge for accurate PPB determination. In this research work, two approaches were used in the method development and qualification for PPB assessment of RDV and TAF. For RDV, dichlorvos was used to inhibit esterase activity to stabilize the prodrug in plasma during equilibrium dialysis (ED). The impact of dichlorvos on protein binding was evaluated and determined to be insignificant by comparing the unbound fraction (f
MeSH term(s)	Humans ; Tenofovir ; Anti-HIV Agents/therapeutic use ; Protein Binding ; Prodrugs/metabolism ; Dichlorvos/therapeutic use ; Adenine ; Alanine/analogs & derivatives ; Blood Proteins/metabolism ; HIV Infections/drug therapy ; Adenosine Monophosphate/analogs & derivatives
Chemical Substances	Tenofovir (99YXE507IL) ; Anti-HIV Agents ; Prodrugs ; remdesivir (3QKI37EEHE) ; Dichlorvos (7U370BPS14) ; Adenine (JAC85A2161) ; Alanine (OF5P57N2ZX) ; Blood Proteins ; Adenosine Monophosphate (415SHH325A)
Language	English
Publishing date	2023-09-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	3151-3
ISSN	1520-6017 ; 0022-3549
ISSN (online)	1520-6017
ISSN	0022-3549
DOI	10.1016/j.xphs.2023.09.009
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Article ; Online: Reply to Yan and Muller, "Single-Cell RNA Sequencing Supports Preferential Bioactivation of Remdesivir in the Liver".

Murakami, Eisuke / Bilello, John / Li, Ruidong / Li, Li / Porter, Danielle / Humeniuk, Rita / Mackman, Richard / Cihlar, Tomas / Osinusi, Anu / Feng, Joy

Antimicrobial agents and chemotherapy

2021 Volume 65, Issue 10, Page(s) e0139421

MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Alanine/analogs & derivatives ; Liver ; Sequence Analysis, RNA
Chemical Substances	remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2021-08-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	217602-6
ISSN	1098-6596 ; 0066-4804
ISSN (online)	1098-6596
ISSN	0066-4804
DOI	10.1128/AAC.01394-21
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Article ; Online: Concise review: erythroid versus myeloid lineage commitment: regulating the master regulators.

Wolff, Linda / Humeniuk, Rita

Stem cells (Dayton, Ohio)

2013 Volume 31, Issue 7, Page(s) 1237–1244

Abstract: Developmental processes, like blood formation, are orchestrated by transcriptional networks. Those transcriptional networks are highly responsive to various environmental stimuli and affect common precursors resulting in increased production of cells of ... ...

Abstract	Developmental processes, like blood formation, are orchestrated by transcriptional networks. Those transcriptional networks are highly responsive to various environmental stimuli and affect common precursors resulting in increased production of cells of the erythroid lineage or myeloid lineage (granulocytes, neutrophils, and macrophages). A significant body of knowledge has accumulated describing transcription factors that drive differentiation of these two major cellular pathways, in particular the antagonistic master regulators such as GATA-1 and PU.1. However, little is known about factors that work upstream of master regulators to enhance differentiation toward one lineage. These functions become especially important under various stress conditions like sudden loss of red blood cells or pathogen infection. This review describes recent studies that begin to provide evidence for such factors. An increased understanding of factors regulating cellular commitment will advance our understanding of the etiology of diseases like anemia, cancer, and possibly other blood related disorders.
MeSH term(s)	Animals ; Cell Differentiation/physiology ; Cell Lineage ; Erythroid Cells/cytology ; Humans ; Myeloid Cells/cytology
Language	English
Publishing date	2013-07
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1143556-2
ISSN	1549-4918 ; 1066-5099
ISSN (online)	1549-4918
ISSN	1066-5099
DOI	10.1002/stem.1379
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Article ; Online: Pharmacokinetics, safety, and tolerability of inhaled remdesivir in healthy participants.

Humeniuk, Rita / Juneja, Kavita / Chen, Shuguang / Ellis, Scott / Anoshchenko, Olena / Xiao, Deqing / Share, Aaron / Johnston, Matthew / Davies, Santosh / DeZure, Adam / Llewellyn, Joe / Osinusi, Anu / Winter, Helen / Girish, Sandhya / Palaparthy, Ramesh / Dresser, Mark

Clinical and translational science

2023 Volume 16, Issue 11, Page(s) 2276–2288

Abstract: Intravenous remdesivir (RDV) is US Food and Drug Administration-approved for hospitalized and nonhospitalized individuals with coronavirus disease 2019. RDV undergoes intracellular metabolic activation to form the active triphosphate, GS-443902, and ... ...

Abstract	Intravenous remdesivir (RDV) is US Food and Drug Administration-approved for hospitalized and nonhospitalized individuals with coronavirus disease 2019. RDV undergoes intracellular metabolic activation to form the active triphosphate, GS-443902, and other metabolites. Alternative administration routes, including localized pulmonary delivery, can lower systemic exposure and maximize exposure at the site of action. This study evaluated the pharmacokinetics (PK) and safety of inhaled RDV in healthy adults. This phase Ia, randomized, placebo-controlled study evaluated inhaled RDV in healthy participants randomized 4:1 to receive RDV or placebo as single doses (4 cohorts) or multiple once-daily doses (3 cohorts). Doses in cohorts 1-6 were administered as an aerosolized solution for inhalation through a sealed facemask; doses in cohort 7 were administered as an aerosolized solution for inhalation through a mouthpiece. Safety was assessed throughout the study. Seventy-two participants were enrolled (inhaled RDV, n = 58 and placebo, n = 14). Following single RDV doses, RDV, GS-704277, and GS-441524 plasma PK parameters indicated dose-proportional increases in area under the concentration-time curve (AUC) extrapolated to infinite time, AUC from time zero to last quantifiable concentration, and maximum observed concentration. Analyte plasma concentrations after multiple RDV doses were consistent with those for single-dose RDV. Analyte plasma exposures were lower when RDV was administered with a mouthpiece versus a sealed facemask. The most common adverse events included nausea, dizziness, and cough. Single- and multiple-dose inhaled RDV exhibited linear and dose-proportional plasma PK. Administration of RDV via inhalation was generally safe and well-tolerated.
MeSH term(s)	Adult ; Humans ; Healthy Volunteers ; Adenosine Monophosphate/adverse effects ; Alanine/adverse effects ; Double-Blind Method ; Dose-Response Relationship, Drug
Chemical Substances	remdesivir (3QKI37EEHE) ; GS-704277 ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2023-09-25
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13627
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Article ; Online: Prediction of Antimalarial Drug Clearance in Children: A Comparison of Three Different Interspecies Scaling Methods.

Mahmood, Iftekhar / Cheng, Anna / Brauer, Edward / Humeniuk, Rita

European journal of drug metabolism and pharmacokinetics

2016 Volume 41, Issue 6, Page(s) 767–775

Abstract: Background and objective: Allometric scaling is extensively used for the prediction of pharmacokinetic parameters from animals to humans and is often used for the selection of first-in-human dose. Allometric scaling can also be used to predict a ... ...

Abstract	Background and objective: Allometric scaling is extensively used for the prediction of pharmacokinetic parameters from animals to humans and is often used for the selection of first-in-human dose. Allometric scaling can also be used to predict a pharmacokinetic parameter in children from adult data including animal species such as rat and dog. The current study was undertaken to evaluate if the clearances of antimalarial drugs in children with malaria can be predicted allometrically (interspecies scaling) from adult rat, dog, and human adult (healthy as well patients with malaria) clearance values. Methods: Three methods [simple allometry, maximum lifespan potential (MLP), and MLP with an empirical correction factor] using clearance values from adult rat, dog, and adult humans with and without malaria were used for the prediction of antimalarial drug clearance in children with malaria. Results: The results of this study indicated that the simple allometry would systematically over-predict antimalarial drug clearance in children with malaria whereas the application of MLP would under-predict the clearances of these drugs in children. Therefore, an empirical correction factor was introduced to MLP which substantially improved the antimalarial drug clearances in children. Conclusions: Overall, the results of the study indicated that interspecies scaling using adult rat, dog, and human clearance values of antimalarial drugs could possibly be used to predict drug clearance in children with malaria of different age groups and may be useful during pediatric drug development of antimalarial drugs.
Language	English
Publishing date	2016-12
Publishing country	France
Document type	Journal Article
ZDB-ID	196729-0
ISSN	2107-0180 ; 0398-7639 ; 0378-7966
ISSN (online)	2107-0180
ISSN	0398-7639 ; 0378-7966
DOI	10.1007/s13318-015-0305-2
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Article ; Online: The determination of Sulfobutylether β-Cyclodextrin Sodium (SBECD) by LC-MS/MS and its application in remdesivir pharmacokinetics study for pediatric patients.

Yang, Zhengdong / Xiao, Deqing / Ling, Kah Hiing John / Tarnowski, Thomas / Humeniuk, Rita / Parmentier, Bryan / Fu, Yu-Hui Ann / Johnson, Eric / Luna, Marsha L / Goudarzi, Habibi / Cheng, Quan

Journal of pharmaceutical and biomedical analysis

2022 Volume 212, Page(s) 114646

Abstract: SBECD (Captisol®) with an average degree of substitution of 6.5 sulfobutylether functional groups (SBE = 6.5), is a solubility enhancer for remdesivir (RDV) and a major component in Veklury, which was approved by FDA for the treatment of patients with ... ...

Abstract	SBECD (Captisol®) with an average degree of substitution of 6.5 sulfobutylether functional groups (SBE = 6.5), is a solubility enhancer for remdesivir (RDV) and a major component in Veklury, which was approved by FDA for the treatment of patients with COVID-19 over 12 years old and weighing over 40 kg who require hospitalization. SBECD is cleared mainly by renal filtration, thus, potential accumulation of SBECD in the human body is a concern for patients dosed with Veklury with compromised renal function. An LC-MS/MS method was developed and validated for specific, accurate, and precise determination of SBECD concentrations in human plasma. In this method, the hexa-substituted species, SBE6, was selected for SBECD quantification, and the mass transition from its dicharged molecular ion [(M-2H)/2]
MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Alanine/analogs & derivatives ; COVID-19/drug therapy ; Child ; Chromatography, Liquid ; Humans ; SARS-CoV-2 ; Sodium ; Tandem Mass Spectrometry/methods ; beta-Cyclodextrins
Chemical Substances	beta-Cyclodextrins ; SBE4-beta-cyclodextrin (2PP9364507) ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Sodium (9NEZ333N27) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2022-02-08
Publishing country	England
Document type	Journal Article
ZDB-ID	604917-5
ISSN	1873-264X ; 0731-7085
ISSN (online)	1873-264X
ISSN	0731-7085
DOI	10.1016/j.jpba.2022.114646
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Article ; Online: Safety, Tolerability, and Pharmacokinetics of Remdesivir, An Antiviral for Treatment of COVID-19, in Healthy Subjects.

Humeniuk, Rita / Mathias, Anita / Cao, Huyen / Osinusi, Anu / Shen, Gong / Chng, Estelle / Ling, John / Vu, Amanda / German, Polina

Clinical and translational science

2020 Volume 13, Issue 5, Page(s) 896–906

Abstract: Remdesivir (RDV), a single diastereomeric monophosphoramidate prodrug that inhibits viral RNA polymerases, has potent in vitro antiviral activity against severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). RDV received the US Food and Drug ... ...

Abstract	Remdesivir (RDV), a single diastereomeric monophosphoramidate prodrug that inhibits viral RNA polymerases, has potent in vitro antiviral activity against severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). RDV received the US Food and Drug Administration (FDA)'s emergency use authorization in the United States and approval in Japan for treatment of patients with severe coronavirus disease 2019 (COVID-19). This report describes two phase I studies that evaluated the safety and pharmacokinetics (PKs) of single escalating and multiple i.v. doses of RDV (solution or lyophilized formulation) in healthy subjects. Lyophilized formulation was evaluated for potential future use in clinical trials due to its storage stability in resource-limited settings. All adverse events were grade 1 or 2 in severity. Overall, RDV exhibited a linear profile following single-dose i.v. administration over 2 hours of RDV solution formulation across the dose range of 3-225 mg. Both lyophilized and solution formulations provided comparable PK parameters. High intracellular concentrations of the active triphosphate (~ 220-fold to 370-fold higher than the in vitro half-maximal effective concentration against SARS-CoV-2 clinical isolate) were achieved following infusion of 75 mg or 150 mg lyophilized formulation over 30 minutes or 2 hours. Following multiple-doses of RDV 150 mg once daily for 7 or 14 days, RDV exhibited a PK profile similar to single-dose administration. Metabolite GS-441524 accumulated ~ 1.9-fold after daily dosing. Overall, RDV exhibited favorable safety and PK profiles that supported once-daily dosing.
MeSH term(s)	Adenosine Monophosphate/administration & dosage ; Adenosine Monophosphate/adverse effects ; Adenosine Monophosphate/analogs & derivatives ; Adenosine Monophosphate/pharmacokinetics ; Administration, Intravenous ; Adult ; Alanine/administration & dosage ; Alanine/adverse effects ; Alanine/analogs & derivatives ; Alanine/pharmacokinetics ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Antiviral Agents/pharmacokinetics ; Area Under Curve ; Betacoronavirus/pathogenicity ; COVID-19 ; Coronavirus Infections/blood ; Coronavirus Infections/drug therapy ; Coronavirus Infections/epidemiology ; Coronavirus Infections/virology ; Female ; Healthy Volunteers ; Humans ; Japan ; Male ; Middle Aged ; Pandemics ; Pneumonia, Viral/blood ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/virology ; SARS-CoV-2 ; Young Adult
Chemical Substances	Antiviral Agents ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Keywords	covid19
Language	English
Publishing date	2020-08-05
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.12840
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