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Article ; Online: Filgotinib: A Clinical Pharmacology Review.

Namour, Florence / Anderson, Kacey / Nelson, Cara / Tasset, Chantal

2022 Volume 61, Issue 6, Page(s) 819–832

Abstract: Filgotinib (GS-6034, formerly GLPG0634; ... ...

Abstract	Filgotinib (GS-6034, formerly GLPG0634; Jyseleca
MeSH term(s)	Arthritis, Rheumatoid/drug therapy ; Humans ; Janus Kinase Inhibitors/therapeutic use ; Pharmacology, Clinical ; Pyridines/pharmacokinetics ; Triazoles/pharmacokinetics
Chemical Substances	GLPG0634 ; Janus Kinase Inhibitors ; Pyridines ; Triazoles
Language	English
Publishing date	2022-05-31
Publishing country	Switzerland
Document type	Journal Article ; Review ; Research Support, Non-U.S. Gov't
ZDB-ID	197627-8
ISSN	1179-1926 ; 0312-5963
ISSN (online)	1179-1926
ISSN	0312-5963
DOI	10.1007/s40262-022-01129-y
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Zs.A 1246: Show issues

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Article ; Online: Evaluation of the potential drug interactions mediated through P-gp, OCT2, and MATE1/2K with filgotinib in healthy subjects.

Hsueh, Chia-Hsiang / Anderson, Kacey / Shen, Gong / Yun, Chohee / Qin, Ann / Othman, Ahmed A

Clinical and translational science

2021 Volume 15, Issue 2, Page(s) 361–370

Abstract: Filgotinib, a preferential Janus Kinase-1 inhibitor, is approved in Europe and Japan for treatment of rheumatoid arthritis and is being developed for treatment of other chronic inflammatory diseases. Three drug-drug interactions studies were conducted in ...

Abstract	Filgotinib, a preferential Janus Kinase-1 inhibitor, is approved in Europe and Japan for treatment of rheumatoid arthritis and is being developed for treatment of other chronic inflammatory diseases. Three drug-drug interactions studies were conducted in healthy subjects to evaluate the effect of P-glycoprotein (P-gp) modulation (study 1: P-gp inhibition by itraconazole and study 2: P-gp induction by rifampin) on filgotinib pharmacokinetics and the potential of filgotinib to impact exposure of metformin, an organic cation transporter (OCT) 2 and multidrug and toxin extrusion (MATE) 1/2K substrate (study 3). Co-administration of filgotinib with itraconazole increased filgotinib exposure (maximum concentration [C
MeSH term(s)	ATP Binding Cassette Transporter, Subfamily B, Member 1/metabolism ; Drug Interactions ; Healthy Volunteers ; Humans ; Pyridines/pharmacokinetics ; Triazoles
Chemical Substances	ATP Binding Cassette Transporter, Subfamily B, Member 1 ; GLPG0634 ; Pyridines ; Triazoles
Language	English
Publishing date	2021-09-25
Publishing country	United States
Document type	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.13152
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Article ; Online: Assessment of the Effect of Filgotinib on the Pharmacokinetics of Atorvastatin, Pravastatin, and Rosuvastatin in Healthy Adult Participants.

Anderson, Kacey / Nelson, Cara H / Gong, Qi / Alani, Muhsen / Tarnowski, Thomas / Othman, Ahmed A

Clinical pharmacology in drug development

2021 Volume 11, Issue 2, Page(s) 235–245

Abstract: Filgotinib, an oral Janus kinase-1 preferential inhibitor, is approved in Europe and Japan for adults with rheumatoid arthritis. Patients with rheumatoid arthritis are at higher risk of cardiovascular morbidity/mortality; thus, it is important to ... ...

Abstract	Filgotinib, an oral Janus kinase-1 preferential inhibitor, is approved in Europe and Japan for adults with rheumatoid arthritis. Patients with rheumatoid arthritis are at higher risk of cardiovascular morbidity/mortality; thus, it is important to understand potential drug-drug interactions of filgotinib with lipid-lowering agents. This open-label, randomized, 2-way crossover study evaluated the pharmacokinetics of atorvastatin, pravastatin, and rosuvastatin with and without filgotinib coadministration. Healthy participants (N = 27) received single doses of atorvastatin (40 mg) and of a pravastatin (40 mg)/rosuvastatin (10 mg) cocktail-alone or with filgotinib (200 mg once daily for 11 days)-on 2 different occasions with washout in between. Serial pharmacokinetic blood samples were collected, and safety was assessed. Pharmacokinetic parameters were evaluated using 90% confidence intervals (CI) of the geometric least-squares mean (GLSM) ratio of the test treatment (statin coadministration with filgotinib) vs statin alone, with prespecified lack-of-interaction bounds of 0.70 to 1.43. Coadministration of filgotinib did not affect atorvastatin area under the plasma concentration-time curve extrapolated to infinity (AUC
MeSH term(s)	Adult ; Atorvastatin/adverse effects ; Atorvastatin/pharmacokinetics ; Cross-Over Studies ; Drug Interactions ; Healthy Volunteers ; Humans ; Pravastatin/adverse effects ; Pravastatin/pharmacokinetics ; Pyridines ; Rosuvastatin Calcium ; Triazoles
Chemical Substances	GLPG0634 ; Pyridines ; Triazoles ; Rosuvastatin Calcium (83MVU38M7Q) ; Atorvastatin (A0JWA85V8F) ; Pravastatin (KXO2KT9N0G)
Language	English
Publishing date	2021-09-01
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2649010-9
ISSN	2160-7648 ; 2160-763X
ISSN (online)	2160-7648
ISSN	2160-763X
DOI	10.1002/cpdd.1015
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Article ; Online: Exposure-response relationships for the efficacy and safety of filgotinib and its metabolite GS-829845 in subjects with rheumatoid arthritis based on phase 2 and phase 3 studies.

Meng, Amy / Anderson, Kacey / Nelson, Cara / Ni, Liyun / Chuang, Shu-Min / Bellanti, Francesco / Chang, Peter / Comisar, Craig / Kearney, Brian P / Bartok, Beatrix / Mathias, Anita

British journal of clinical pharmacology

2022 Volume 88, Issue 7, Page(s) 3211–3221

Abstract: Aims: Filgotinib is a potent, oral, JAK1-preferential inhibitor for the treatment of rheumatoid arthritis (RA). This report describes exposure-response (ER) analyses of filgotinib for dose confirmation based on three phase 3 and two phase 2 studies in ... ...

Abstract	Aims: Filgotinib is a potent, oral, JAK1-preferential inhibitor for the treatment of rheumatoid arthritis (RA). This report describes exposure-response (ER) analyses of filgotinib for dose confirmation based on three phase 3 and two phase 2 studies in moderate to severe RA patients. Methods: The pharmacokinetic exposures used in ER analyses were derived from population pharmacokinetic analysis. The exposure-efficacy relationships were assessed for efficacy endpoints (ACR20/50/70 and DAS28) over effective area under curve (AUC Results: The nonlinear logistic regression showed increasing response with increasing exposure, with exposures at 200 mg dose primarily residing on the curve plateau. Also, AUC Conclusions: ER analyses confirmed that filgotinib produced more robust therapeutic effects across the exposure range observed at 200 mg once daily compared to lower doses, and collectively with the lack of exposure-safety relationship, the 200 mg once daily dose was supported for commercialization.
MeSH term(s)	Antirheumatic Agents/adverse effects ; Arthritis, Rheumatoid/drug therapy ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Humans ; Janus Kinase Inhibitors/adverse effects ; Pyridines/adverse effects ; Treatment Outcome ; Triazoles/adverse effects
Chemical Substances	Antirheumatic Agents ; GLPG0634 ; Janus Kinase Inhibitors ; Pyridines ; Triazoles
Language	English
Publishing date	2022-02-14
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15239
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Zs.A 1118: Show issues

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Article ; Online: Lack of Drug-Drug Interaction Between Filgotinib, a Selective JAK1 Inhibitor, and Oral Hormonal Contraceptives Levonorgestrel/Ethinyl Estradiol in Healthy Volunteers.

Begley, Rebecca / Anderson, Kacey / Watkins, Timothy R / Weng, Winnie / Ampaw, Lorraine / Qin, Ann / Kearney, Brian P / Mathias, Anita

Clinical pharmacology in drug development

2020 Volume 10, Issue 4, Page(s) 376–383

Abstract: Filgotinib (FIL) is a potent and selective JAK1 inhibitor in clinical development for treatment of severe inflammatory diseases. A drug-drug interaction study to evaluate the potential effect of FIL on the pharmacokinetics (PK) of the oral contraceptive ... ...

Abstract	Filgotinib (FIL) is a potent and selective JAK1 inhibitor in clinical development for treatment of severe inflammatory diseases. A drug-drug interaction study to evaluate the potential effect of FIL on the pharmacokinetics (PK) of the oral contraceptive levonorgestrel (LEVO)/ethinyl estradiol (EE) was conducted. This was a phase 1, open-label, randomized, crossover study in healthy female subjects (N = 24). Subjects received a single dose of LEVO (150 μg)/EE (30 μg) alone (reference), or in combination with multiple-dose FIL (200 mg once daily for 15 days; test). Intensive PK sampling was conducted, and safety was assessed throughout the study. PK interactions were evaluated using 90% confidence intervals of the geometric least squares mean ratios of the test versus reference treatments. All 24 subjects enrolled completed study treatments. Coadministration of FIL with the oral contraceptive did not alter the PK of LEVO and EE; the 90% confidence intervals of the geometric least squares mean ratios were contained within bioequivalence bounds (80%-125%). Exposures of FIL were consistent with observed clinical exposure data. Study treatments were generally well tolerated. All adverse events were mild. Coadministration with FIL did not alter the PK of LEVO/EE, and hormonal contraceptives can serve as an effective contraception method for subjects on FIL treatment.
MeSH term(s)	Adult ; Contraceptives, Oral, Hormonal/adverse effects ; Contraceptives, Oral, Hormonal/pharmacokinetics ; Cross-Over Studies ; Drug Combinations ; Drug Interactions ; Ethinyl Estradiol/adverse effects ; Ethinyl Estradiol/pharmacokinetics ; Female ; Humans ; Janus Kinase 1/antagonists & inhibitors ; Janus Kinase Inhibitors/adverse effects ; Janus Kinase Inhibitors/pharmacology ; Levonorgestrel/adverse effects ; Levonorgestrel/pharmacokinetics ; Middle Aged ; Pyridines/adverse effects ; Pyridines/pharmacology ; Triazoles/adverse effects ; Triazoles/pharmacology ; Young Adult
Chemical Substances	Contraceptives, Oral, Hormonal ; Drug Combinations ; GLPG0634 ; Janus Kinase Inhibitors ; Pyridines ; Triazoles ; ethinyl estradiol, levonorgestrel drug combination ; Ethinyl Estradiol (423D2T571U) ; Levonorgestrel (5W7SIA7YZW) ; JAK1 protein, human (EC 2.7.10.2) ; Janus Kinase 1 (EC 2.7.10.2)
Language	English
Publishing date	2020-09-28
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2649010-9
ISSN	2160-7648 ; 2160-763X
ISSN (online)	2160-7648
ISSN	2160-763X
DOI	10.1002/cpdd.870
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Article ; Online: Effect of Hypothermia and Targeted Temperature Management on Drug Disposition and Response Following Cardiac Arrest: A Comprehensive Review of Preclinical and Clinical Investigations.

Anderson, Kacey B / Poloyac, Samuel M / Kochanek, Patrick M / Empey, Philip E

Therapeutic hypothermia and temperature management

2016 Volume 6, Issue 4, Page(s) 169–179

Abstract: Targeted temperature management (TTM) has been shown to reduce mortality and improve neurological outcomes in out-of-hospital cardiac arrest (CA) patients and in neonates with hypoxic-ischemic encephalopathy (HIE). TTM has also been associated with ... ...

Abstract	Targeted temperature management (TTM) has been shown to reduce mortality and improve neurological outcomes in out-of-hospital cardiac arrest (CA) patients and in neonates with hypoxic-ischemic encephalopathy (HIE). TTM has also been associated with adverse drug events in the critically ill patient due to its effect on drug pharmacokinetics (PKs) and pharmacodynamics (PDs). We aim to evaluate the current literature on the effect of TTM on drug PKs and PDs following CA. MEDLINE/PubMed databases were searched for publications, which include the MeSH terms hypothermia, drug metabolism, drug transport, P450, critical care, cardiac arrest, hypoxic-ischemic encephalopathy, pharmacokinetics, and pharmacodynamics between July 2006 and October 2015. Twenty-three studies were included in this review. The studies demonstrate that hypothermia impacts PK parameters and increases concentrations of cytochrome-P450-metabolized drugs in the cooling and rewarming phase. Furthermore, the current data demonstrate a combined effect of CA and hypothermia on drug PK. Importantly, these effects can last greater than 4-5 days post-treatment. Limited evidence suggests hypothermia-mediated changes in the Phase II metabolism and the Phase III transport of drugs. Hypothermia also has been shown to potentially decrease the effect of specific drugs at the receptor level. Therapeutic hypothermia, as commonly deployed/applied during TTM, alters PK, and elevates concentrations of several commonly used medications. Hypothermia-mediated effects are an important factor when dosing and monitoring patients undergoing TTM treatment.
MeSH term(s)	Animals ; Anti-Infective Agents/administration & dosage ; Anti-Infective Agents/adverse effects ; Anti-Infective Agents/pharmacokinetics ; Anticonvulsants/administration & dosage ; Anticonvulsants/adverse effects ; Anticonvulsants/pharmacokinetics ; Biological Availability ; Body Temperature Regulation ; Drug Dosage Calculations ; Drug Interactions ; Heart Arrest/metabolism ; Heart Arrest/physiopathology ; Heart Arrest/therapy ; Humans ; Hypnotics and Sedatives/administration & dosage ; Hypnotics and Sedatives/adverse effects ; Hypnotics and Sedatives/pharmacokinetics ; Hypothermia, Induced/adverse effects ; Hypothermia, Induced/methods ; Platelet Aggregation Inhibitors/administration & dosage ; Platelet Aggregation Inhibitors/adverse effects ; Platelet Aggregation Inhibitors/pharmacokinetics ; Rewarming ; Risk Factors ; Treatment Outcome
Chemical Substances	Anti-Infective Agents ; Anticonvulsants ; Hypnotics and Sedatives ; Platelet Aggregation Inhibitors
Language	English
Publishing date	2016-12
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2609342-X
ISSN	2153-7933 ; 2153-7658
ISSN (online)	2153-7933
ISSN	2153-7658
DOI	10.1089/ther.2016.0003
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Article ; Online: Filgotinib, a JAK1 Inhibitor, Has No Effect on QT Interval in Healthy Subjects.

Anderson, Kacey / Xin, Yan / Zheng, Hao / Yun, Chohee / Kwan, Ellen / Qin, Ann / Namour, Florence / Kearney, Brian P / Mathias, Anita

Clinical pharmacology in drug development

2019 Volume 9, Issue 1, Page(s) 32–40

Abstract: Filgotinib, a selective inhibitor of Janus kinase 1, is being developed for the treatment of chronic inflammatory diseases. Electrocardiograms evaluated the effect of filgotinib on the corrected QT (QTc) interval in 52 healthy subjects who received each ... ...

Abstract	Filgotinib, a selective inhibitor of Janus kinase 1, is being developed for the treatment of chronic inflammatory diseases. Electrocardiograms evaluated the effect of filgotinib on the corrected QT (QTc) interval in 52 healthy subjects who received each of 4 treatments: filgotinib 200 mg (therapeutic dose), 450 mg (supratherapeutic dose), and placebo, each administered once daily for 7 days, and a single dose of moxifloxacin 400 mg (positive control). Plasma samples were collected for pharmacokinetic analysis. The QTc interval was calculated using Fridericia's correction factor (QTcF) or an individual correction factor (QTcI). The relationship between plasma concentrations of filgotinib and its major metabolite and time-matched, baseline-adjusted, placebo-corrected QTc (ΔΔQTc) was evaluated. Filgotinib did not prolong QTcF or QTcI and using an appropriate mixed-effect model, the upper limit of the 2-sided 90% confidence interval for ΔΔQTc for each filgotinib dose (200 and 450 mg) remained below 10 milliseconds at all postdose time points. There were no clinically relevant relationships between QTc interval and plasma concentrations of filgotinib or its major metabolite. Filgotinib, administered at 200 or 450 mg, was generally well tolerated. Results of this thorough QT study demonstrate that filgotinib and its major metabolite are not associated with QTc interval prolongation.
MeSH term(s)	Adult ; Cross-Over Studies ; Double-Blind Method ; Electrocardiography/drug effects ; Female ; Healthy Volunteers ; Heart Rate/drug effects ; Humans ; Janus Kinase 1/antagonists & inhibitors ; Long QT Syndrome ; Male ; Middle Aged ; Protein Kinase Inhibitors/blood ; Protein Kinase Inhibitors/pharmacokinetics ; Protein Kinase Inhibitors/pharmacology ; Pyridines/blood ; Pyridines/pharmacokinetics ; Pyridines/pharmacology ; Triazoles/blood ; Triazoles/pharmacokinetics ; Triazoles/pharmacology
Chemical Substances	GLPG0634 ; Protein Kinase Inhibitors ; Pyridines ; Triazoles ; JAK1 protein, human (EC 2.7.10.2) ; Janus Kinase 1 (EC 2.7.10.2)
Language	English
Publishing date	2019-12-02
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2649010-9
ISSN	2160-7648 ; 2160-763X
ISSN (online)	2160-7648
ISSN	2160-763X
DOI	10.1002/cpdd.755
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Article ; Online: The Relative Bioavailability and Effects of Food and Acid-Reducing Agents on Filgotinib Tablets in Healthy Subjects.

Anderson, Kacey / Zheng, Hao / Kotecha, Mona / Cuvin, Jennifer / Scott, Bob / Sharma, Shringi / Qin, Ann Ran-Ran / Namour, Florence / Xin, Yan

Clinical pharmacology in drug development

2019 Volume 8, Issue 5, Page(s) 585–594

Abstract: Filgotinib is a potent, selective Janus kinase-1 inhibitor being developed to treat chronic inflammatory diseases. This phase 1 study in healthy subjects evaluated the relative bioavailability of filgotinib maleate tablets versus the reference tablet ( ... ...

Abstract	Filgotinib is a potent, selective Janus kinase-1 inhibitor being developed to treat chronic inflammatory diseases. This phase 1 study in healthy subjects evaluated the relative bioavailability of filgotinib maleate tablets versus the reference tablet (filgotinib hydrochloride) and effects of food and acid-reducing agents (ARAs) on the pharmacokinetics of filgotinib and its major metabolite. Noncompartmental pharmacokinetic parameters of filgotinib and its major metabolite were compared between the 2 tablets at 100- and 200-mg doses and with or without food or ARAs. Filgotinib maleate tablets resulted in equivalent plasma exposures (area under concentration-time curve to infinity [AUC
MeSH term(s)	Administration, Oral ; Adult ; Biological Availability ; Famotidine/pharmacology ; Female ; Food-Drug Interactions ; Healthy Volunteers ; Humans ; Janus Kinase 1/antagonists & inhibitors ; Male ; Middle Aged ; Omeprazole/pharmacology ; Protein Kinase Inhibitors/blood ; Protein Kinase Inhibitors/pharmacokinetics ; Proton Pump Inhibitors/pharmacology ; Pyridines/blood ; Pyridines/pharmacokinetics ; Tablets ; Triazoles/blood ; Triazoles/pharmacokinetics ; Young Adult
Chemical Substances	GLPG0634 ; Protein Kinase Inhibitors ; Proton Pump Inhibitors ; Pyridines ; Tablets ; Triazoles ; Famotidine (5QZO15J2Z8) ; JAK1 protein, human (EC 2.7.10.2) ; Janus Kinase 1 (EC 2.7.10.2) ; Omeprazole (KG60484QX9)
Language	English
Publishing date	2019-02-15
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2649010-9
ISSN	2160-7648 ; 2160-763X
ISSN (online)	2160-7648
ISSN	2160-763X
DOI	10.1002/cpdd.659
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Article ; Online: Age predicts cytokine kinetics and innate immune cell activation following intranasal delivery of IFNγ and GM-CSF in a mouse model of RSV infection.

Eichinger, Katherine M / Resetar, Erin / Orend, Jacob / Anderson, Kacey / Empey, Kerry M

Cytokine

2017 Volume 97, Page(s) 25–37

Abstract: Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in young children and is further associated with increased healthcare utilization and cost of care in the first years of life. Severe RSV disease during infancy ... ...

Abstract	Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in young children and is further associated with increased healthcare utilization and cost of care in the first years of life. Severe RSV disease during infancy has also been linked to the later development of allergic asthma, yet there remains no licensed RSV vaccine or effective treatment. Pre-clinical and clinical studies have shown that disease severity and development of allergic asthma are associated with differences in cytokine production. As a result, stimulation of the innate host immune response with immune potentiators is gaining attention for their prospective application in populations with limited immune responses to antigenic stimuli or against pathogens for which vaccines do not exist. Specifically, macrophage-activating cytokines such as interferon gamma (IFNγ) and granulocyte colony-stimulating factor (GM-CSF) are commercially available immune potentiators used to prevent infections in patients with chronic granulomatous disease and febrile neutropenia, respectively. Moreover, an increasing number of reports describe the protective function of IFNγ and GM-CSF as vaccine adjuvants. Although a positive correlation between cytokine production and age has previously been reported, little is known about age-dependent cytokine metabolism or immune activating responses in infant compared to adult lungs. Here we use a non-compartmental pharmacokinetic model in naïve and RSV-infected infant and adult BALB/c mice to determine the effect of age on IFNγ and GM-CSF elimination and innate cell activation following intranasal delivery.
MeSH term(s)	Administration, Intranasal ; Age Factors ; Animals ; Disease Models, Animal ; Granulocyte-Macrophage Colony-Stimulating Factor/administration & dosage ; Granulocyte-Macrophage Colony-Stimulating Factor/blood ; Granulocyte-Macrophage Colony-Stimulating Factor/immunology ; Granulocyte-Macrophage Colony-Stimulating Factor/pharmacokinetics ; Immunity, Innate/drug effects ; Interferon-gamma/administration & dosage ; Interferon-gamma/blood ; Interferon-gamma/immunology ; Interferon-gamma/pharmacokinetics ; Kinetics ; Lung/drug effects ; Lung/immunology ; Lung/virology ; Macrophage Activation ; Mice ; Mice, Inbred BALB C ; Prospective Studies ; Respiratory Syncytial Virus Infections/immunology ; Respiratory Syncytial Virus Infections/virology ; Respiratory Syncytial Virus, Human/physiology
Chemical Substances	Interferon-gamma (82115-62-6) ; Granulocyte-Macrophage Colony-Stimulating Factor (83869-56-1)
Language	English
Publishing date	2017-05-27
Publishing country	England
Document type	Journal Article
ZDB-ID	1018055-2
ISSN	1096-0023 ; 1043-4666
ISSN (online)	1096-0023
ISSN	1043-4666
DOI	10.1016/j.cyto.2017.05.019
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Article ; Online: A rapid UPLC-MS/MS assay for eicosanoids in human plasma: Application to evaluate niacin responsivity.

Miller, Tricia M / Poloyac, Samuel M / Anderson, Kacey B / Waddell, Brooke L / Messamore, Erik / Yao, Jeffrey K

Prostaglandins, leukotrienes, and essential fatty acids

2017 Volume 136, Page(s) 153–159

Abstract: A rapid and sensitive method using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) was developed to simultaneously quantify hydroxyeicosatetraenoic (HETE), dihydroxyeicosatrienoic (DiHETrE), epoxyeicosatrienoic acid (EET), ... ...

Abstract	A rapid and sensitive method using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) was developed to simultaneously quantify hydroxyeicosatetraenoic (HETE), dihydroxyeicosatrienoic (DiHETrE), epoxyeicosatrienoic acid (EET), and prostaglandin metabolites of arachidonic acid in human plasma. Sample preparation consisted of solid phase extraction with Oasis HLB (30mg) cartridges for all metabolites. Separation of HETEs, EETs, and DiHETrEs was achieved on an Acquity UPLC BEH C18, 1.7µm (100×2.1mm) reversed-phase column (Waters Corp, Millford, MA) with negative electrospray ionization mass spectrometric detection. A second injection of the same extracted sample allowed for separation and assessment of prostaglandin metabolites under optimized UPLC-MS/MS conditions. Additionally, the endogenous levels of these metabolites in five different matrices were determined in order to select the optimal matrix for assay development. Human serum albumin was shown to have the least amount of endogenous metabolites, a recovery efficiency of 79-100% and a matrix effect of 71 - 100%. Linear calibration curves ranging from 0.416 to 66.67ng/ml were validated. Inter-assay and intra-assay variance was less than 15% at most concentrations. This method was successfully applied to quantify metabolite levels in plasma samples of healthy control subjects receiving niacin administration to evaluate the association between niacin administration and eicosanoid plasma level response.
MeSH term(s)	Chromatography, Liquid/methods ; Eicosanoids/blood ; Healthy Volunteers ; Humans ; Niacin/administration & dosage ; Serum Albumin, Human/metabolism ; Solid Phase Extraction ; Tandem Mass Spectrometry/methods
Chemical Substances	Eicosanoids ; Niacin (2679MF687A) ; Serum Albumin, Human (ZIF514RVZR)
Language	English
Publishing date	2017-01-18
Publishing country	Scotland
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	286714-x
ISSN	1532-2823 ; 0952-3278
ISSN (online)	1532-2823
ISSN	0952-3278
DOI	10.1016/j.plefa.2017.01.003
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