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Article ; Online: Single- and Multiple-Dose Pharmacokinetics of Gefapixant (MK-7264), a P2X3 Receptor Antagonist, in Healthy Adults.

Nussbaum, Jesse C / Hussain, Azher / Butera, Peter / Ford, Anthony P / Kitt, Michael M / O'Neill, Edward A / Smith, Steven / Vargas, Gabriel / O'Reilly, Terry / Wynne, Chris / Stoch, S Aubrey / Iwamoto, Marian

Journal of clinical pharmacology

2024

Abstract: Gefapixant (MK-7264, RO4926219, AF-219) is a first-in-class P2X3 antagonists being developed to treat refractory or unexplained chronic cough. The initial single- and multiple-dose safety, tolerability, and pharmacokinetics of gefapixant at doses ranging ...

Abstract	Gefapixant (MK-7264, RO4926219, AF-219) is a first-in-class P2X3 antagonists being developed to treat refractory or unexplained chronic cough. The initial single- and multiple-dose safety, tolerability, and pharmacokinetics of gefapixant at doses ranging from 7.5 to 1800 mg were assessed in four clinical trials. Following single-dose administration of 10-450 mg, the pharmacokinetic (PK) profile of gefapixant in plasma and urine demonstrated low inter-subject variability and a dose-proportional exposure. Following administration of multiple doses twice daily, the plasma exposures were dose-proportional at doses ranging from 7.5 to 50 mg and less than dose-proportional at doses ranging from 100 to 1800 mg. The time to mean peak drug concentration ranged from 2 to 3 h post-dose, and steady state was achieved by 7 days after dosing, with an accumulation ratio of approximately 2, comparing data from day 1 to steady state. The mean apparent terminal half-life ranged from 8.2 to 9.6 h. Gefapixant was primarily excreted unmodified in urine. Gefapixant was well tolerated following single-dose administration up to 1800 mg and multiple doses up to 1800 mg twice daily; there were no serious adverse events (AEs) reported. The most common AE reported was dysgeusia. The PK profile supports a twice-daily dosing regimen.
Language	English
Publishing date	2024-04-23
Publishing country	England
Document type	Journal Article
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1002/jcph.2442
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Article ; Online: Estradiol and the control of food intake.

Butera, Peter C

Physiology & behavior

2009 Volume 99, Issue 2, Page(s) 175–180

Abstract: ... women [Sodersten P, Bergh C. Anorexia nervosa: towards a neurobiologically based therapy. Eur J ...

Abstract	Gonadal steroids are among the many factors that influence food intake and body weight in mammals. Hormonal effects on these processes are particularly striking in female rats, which show large increases in food intake and body weight after ovariectomy. A key role of estradiol in the control of food intake and energy balance in humans is evidenced by the fact that the incidence of obesity increases greatly after menopause [American College of Obstetricians and Gynecologists. Body mass index and insulin resistance. Obstet Gynecol 2004;104:5s-10]. The actions of estradiol on neural systems that regulate eating may also account in part for sex differences in food intake and eating disorders, which occur much more frequently in young women [Sodersten P, Bergh C. Anorexia nervosa: towards a neurobiologically based therapy. Eur J Pharmacol 2003;480:67-74]. This paper presents a minireview of research examining the changes in feeding that occur during the ovarian cycle, the effects of estradiol withdrawal and replacement on food intake and body weight, and the neurobiological mechanisms by which estradiol influences feeding behavior. A model of hormone action on food intake that emerges from this research views estradiol as an indirect control of eating and meal size, producing changes in feeding behavior by modulating the central processing of both satiating and orexigenic peptides that represent direct controls of eating. Some of the shortcomings of the model and directions for future research are discussed.
MeSH term(s)	Animals ; Body Weight/drug effects ; Cholecystokinin/metabolism ; Cholecystokinin/pharmacology ; Eating/drug effects ; Estradiol/metabolism ; Estradiol/pharmacology ; Female ; Ghrelin/pharmacology ; Humans ; Male ; Ovariectomy ; Satiety Response/drug effects
Chemical Substances	Ghrelin ; Estradiol (4TI98Z838E) ; Cholecystokinin (9011-97-6)
Language	English
Publishing date	2009-06-23
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	3907-x
ISSN	1873-507X ; 0031-9384
ISSN (online)	1873-507X
ISSN	0031-9384
DOI	10.1016/j.physbeh.2009.06.010
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Article ; Online: Specific tractography differences in autism compared to developmental coordination disorder.

Kilroy, Emily / Gerbella, Marzio / Cao, Lei / Molfese, Peter / Butera, Christiana / Harrison, Laura / Jayashankar, Aditya / Rizzolatti, Giacomo / Aziz-Zadeh, Lisa

Scientific reports

2022 Volume 12, Issue 1, Page(s) 19246

Abstract: About 85% of children with autism spectrum disorder (ASD) experience comorbid motor impairments, making it unclear whether white matter abnormalities previously found in ASD are related to social communication deficits, the hallmark of ASD, or instead ... ...

Abstract	About 85% of children with autism spectrum disorder (ASD) experience comorbid motor impairments, making it unclear whether white matter abnormalities previously found in ASD are related to social communication deficits, the hallmark of ASD, or instead related to comorbid motor impairment. Here we aim to understand specific white matter signatures of ASD beyond those related to comorbid motor impairment by comparing youth (aged 8-18) with ASD (n = 22), developmental coordination disorder (DCD; n = 16), and typically developing youth (TD; n = 22). Diffusion weighted imaging was collected and quantitative anisotropy, radial diffusivity, mean diffusivity, and axial diffusivity were compared between the three groups and correlated with social and motor measures. Compared to DCD and TD groups, diffusivity differences were found in the ASD group in the mid-cingulum longitudinal and u-fibers, the corpus callosum forceps minor/anterior commissure, and the left middle cerebellar peduncle. Compared to the TD group, the ASD group had diffusivity differences in the right inferior frontal occipital/extreme capsule and genu of the corpus callosum. These diffusion differences correlated with emotional deficits and/or autism severity. By contrast, children with DCD showed unique abnormality in the left cortico-spinal and cortico-pontine tracts.Trial Registration All data are available on the National Institute of Mental Health Data Archive: https://nda.nih.gov/edit_collection.html?id=2254 .
MeSH term(s)	Adolescent ; Child ; Humans ; Autism Spectrum Disorder/diagnostic imaging ; Autistic Disorder/diagnostic imaging ; Diffusion Tensor Imaging ; Motor Skills Disorders/diagnostic imaging ; White Matter/diagnostic imaging
Language	English
Publishing date	2022-11-14
Publishing country	England
Document type	Clinical Trial ; Journal Article
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-022-21538-0
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Article ; Online: Cyclic estradiol treatment modulates the orexigenic effects of ghrelin in ovariectomized rats.

Butera, Peter C / Clough, Shannon J / Bungo, Alexandria

Pharmacology, biochemistry, and behavior

2014 Volume 124, Page(s) 356–360

Abstract: Data from a wide variety of mammalian species indicate that feeding behavior can be influenced by changes in endogenous estrogens and exogenous estrogenic treatments. Ghrelin is an important physiological signal for the regulation of energy balance, and ... ...

Abstract	Data from a wide variety of mammalian species indicate that feeding behavior can be influenced by changes in endogenous estrogens and exogenous estrogenic treatments. Ghrelin is an important physiological signal for the regulation of energy balance, and ghrelin treatment increases eating and body weight in male rodents. The following studies evaluated the hypothesis that the inhibitory effects of estradiol on feeding involve interactions with orexigenic peptides by examining the ability of estradiol to modulate the behavioral effects of ghrelin in female rats. In these experiments, adult rats were ovariectomized and assigned to an estradiol benzoate (EB) or an oil (control) group. Three weeks after ovariectomy, animals received two daily subcutaneous injections of EB or the oil vehicle. Animals then received intraperitoneal (ip) injections of ghrelin (6.0 or 12.0 nmol) or saline during the nocturnal and diurnal periods three days after the first injection of estradiol or oil. Food intake, meal size, and meal number were determined during the 2-hour period following ghrelin or saline treatments. Ghrelin significantly increased food intake during nocturnal tests in oil-treated but not estradiol-treated rats. The hyperphagic effects of ghrelin on nocturnal food intake were also accompanied by an increase in meal size, and this effect of ghrelin on meal size was attenuated in estradiol-treated females. These findings support the hypothesis that the effects of estradiol on feeding behavior involve an attenuation of orexigenic signals, possibly by modulating the effects of the peripheral ghrelin signal on hypothalamic neuropeptides involved in the control of food intake.
MeSH term(s)	Animals ; Body Weight ; Circadian Rhythm ; Drug Interactions ; Estradiol/administration & dosage ; Estradiol/pharmacology ; Feeding Behavior/drug effects ; Female ; Ghrelin/drug effects ; Ovariectomy ; Rats ; Rats, Long-Evans
Chemical Substances	Ghrelin ; Estradiol (4TI98Z838E)
Language	English
Publishing date	2014-07-12
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	191042-5
ISSN	1873-5177 ; 0091-3057
ISSN (online)	1873-5177
ISSN	0091-3057
DOI	10.1016/j.pbb.2014.07.004
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Article ; Online: Transcriptomics of acute myeloid leukaemia core bone marrow biopsies reveals distinct therapy response-specific osteo-mesenchymal profiles.

British journal of haematology

2022 Volume 200, Issue 6, Page(s) 740–754

Abstract: While the bone marrow (BM) microenvironment is significantly remodelled in acute myeloid leukaemia (AML), molecular insight into AML-specific alterations in the microenvironment has been historically limited by the analysis of liquid marrow aspirates ... ...

Abstract	While the bone marrow (BM) microenvironment is significantly remodelled in acute myeloid leukaemia (AML), molecular insight into AML-specific alterations in the microenvironment has been historically limited by the analysis of liquid marrow aspirates rather than core biopsies that contain solid-phase BM stroma. We assessed the effect of anthracycline- and cytarabine-based induction chemotherapy on both haematopoietic and non-haematopoietic cells directly in core BM biopsies using RNA-seq and histological analysis. We compared matched human core BM biopsies at diagnosis and 2 weeks after cytarabine- and anthracycline-based induction therapy in responders (<5% blasts present after treatment) and non-responders (≥5% blasts present after treatment). Our data indicated enrichment in vimentin (VIM), platelet-derived growth factor receptor beta (PDGFRB) and Snail family transcriptional repressor 2 (SNAI2) transcripts in responders, consistent with the reactivation of the mesenchymal population in the BM stroma. Enrichment of osteoblast maturation-related transcripts of biglycan (BGN), osteopontin (SPP1) and osteonectin (SPARC) was observed in non-responders. To the best of our knowledge, this is the first report demonstrating distinct osteogenic and mesenchymal transcriptome profiles specific to AML response to induction chemotherapy assessed directly in core BM biopsies. Detailing treatment response-specific alterations in the BM stroma may inform optimised therapeutic strategies for AML.
MeSH term(s)	Humans ; Bone Marrow/pathology ; Transcriptome ; Leukemia, Myeloid, Acute/drug therapy ; Cytarabine/therapeutic use ; Bone Marrow Cells/pathology ; Anthracyclines/therapeutic use ; Biopsy ; Tumor Microenvironment
Chemical Substances	Cytarabine (04079A1RDZ) ; Anthracyclines
Language	English
Publishing date	2022-11-10
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80077-6
ISSN	1365-2141 ; 0007-1048
ISSN (online)	1365-2141
ISSN	0007-1048
DOI	10.1111/bjh.18513
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Article ; Online: Monitoring plasma nucleosome concentrations to measure disease response and progression in dogs with hematopoietic malignancies.

Wilson-Robles, Heather / Warry, Emma / Miller, Tasha / Jarvis, Jill / Matsushita, Matthew / Miller, Pamela / Herzog, Marielle / Turatsinze, Jean-Valery / Kelly, Theresa K / Butera, S Thomas / Michel, Gaetan

PloS one

2023 Volume 18, Issue 5, Page(s) e0281796

Abstract: ... multiple myeloma. Additionally, C-reactive protein and thymidine kinase-1 levels were recorded.: Results: Plasma ... concentrations correlated better with disease response and progression than either thymidine kinase or C reactive ... Background: Hematopoietic malignancies are extremely common in pet dogs and represent nearly 30 ...

Abstract	Background: Hematopoietic malignancies are extremely common in pet dogs and represent nearly 30% of the malignancies diagnosed in this population each year. Clinicians commonly use existing tools such as physical exam findings, radiographs, ultrasound and baseline blood work to monitor these patients for treatment response and remission. Circulating biomarkers, such as prostate specific antigen or carcinoembryonic antigen, can be useful tools for monitoring treatment response and remission status in human cancer patients. To date, there has a been a lack of useful circulating biomarkers available to veterinary oncology patients. Methods: Circulating plasma nucleosome concentrations were evaluated at diagnosis, throughout treatment and during remission monitoring for 40 dogs with lymphoma, acute myelogenous leukemia and multiple myeloma. Additionally, C-reactive protein and thymidine kinase-1 levels were recorded. Results: Plasma nucleosome concentrations were significantly higher at diagnosis and progressive disease than they were when dogs were in remission. All but two dogs had plasma nucleosome concentrations that returned to the low range during treatment. These two dogs had the shortest progression free and overall survival times. Dogs with the highest plasma nucleosome concentrations had a significantly shorter first progression free survival than dogs with lower plasma nucleosome concentrations at diagnosis. Plasma nucleosome concentrations correlated better with disease response and progression than either thymidine kinase or C reactive protein. Conclusions: Plasma nucleosome concentrations can be a useful tool for treatment monitoring and disease progression in dogs with hematopoietic malignancies.
MeSH term(s)	Male ; Humans ; Dogs ; Animals ; Nucleosomes ; Thymidine Kinase ; Biomarkers ; Neoplasms ; Hematologic Neoplasms/veterinary ; C-Reactive Protein ; Dog Diseases/diagnosis
Chemical Substances	Nucleosomes ; Thymidine Kinase (EC 2.7.1.21) ; Biomarkers ; C-Reactive Protein (9007-41-4)
Language	English
Publishing date	2023-05-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0281796
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Article ; Online: Low microchimeric cell density in tumors suggests alternative antineoplastic mechanism.

Jolis, Timothy W / Brucker, Brenna M / Schorl, Christoph / Butera, James N / Quesenberry, Peter J

Medical oncology (Northwood, London, England)

2017 Volume 34, Issue 4, Page(s) 65

Abstract: Microchimerism has generally been shown to protect against cancer (Gilmore et al. in Exp Hematol 36(9):1073-1077, 2008). The mechanism of how this occurs is an area of intense study, as it may lead to new cancer treatments. The leading theory is that ... ...

Abstract	Microchimerism has generally been shown to protect against cancer (Gilmore et al. in Exp Hematol 36(9):1073-1077, 2008). The mechanism of how this occurs is an area of intense study, as it may lead to new cancer treatments. The leading theory is that microchimeric cells perform immune surveillance by directly fighting cancerous cells and that they also act as stem cells, repairing damaged tissue (Khosrotehrani et al. in JAMA 292:75-80, 2004). However, there is conflicting evidence to support this theory. Several small studies have found few microchimeric cells in tumor tissue (Gadi in Breast Cancer Res Treat 121(1):241-244, 2010; Cirello et al. in Int J Cancer 126:2874-2878, 2010), while another study contradicted these findings by showing microchimeric cells clustered around tumor tissue (O'Donoghue et al. in Reprod Biomed Online 16:382-390, 2008). To date, we have designed the largest and broadest study to investigate this question of whether microchimeric cells really do cluster at tumor tissue. We analyzed 245 samples from a broad range of cancer types. Using PCR for the male chromosome marker TSPY1, we identified only 12 out of 245 samples with microchimerism for a rate of 4.9% (95% confidence interval 2.2-7.6%). Five of these samples were confirmed using Y fluorescence in situ hybridization. This rate of 4.9% microchimerism is the lowest reported in any study. The low percentage of microchimerism observed in our broad study suggests that microchimeric cells do not invade tumors to fight off neoplasm.
MeSH term(s)	Cell Count ; Cell Cycle Proteins/genetics ; Chimerism ; Female ; Humans ; In Situ Hybridization, Fluorescence ; Neoplasms/genetics ; Neoplasms/immunology ; Neoplasms/pathology
Chemical Substances	Cell Cycle Proteins ; TSPY1 protein, human
Language	English
Publishing date	2017-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	1201189-7
ISSN	1559-131X ; 0736-0118 ; 1357-0560
ISSN (online)	1559-131X
ISSN	0736-0118 ; 1357-0560
DOI	10.1007/s12032-017-0921-6
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Article ; Online: Effects of estradiol on food intake and meal patterns for diets that differ in flavor and fat content.

Butera, Peter C / Wojcik, Danielle M / Clough, Shannon J

Physiology & behavior

2009 Volume 99, Issue 1, Page(s) 142–145

Abstract: Apart from the well known inhibitory effects of estradiol on food intake, meal size, and body weight in female rats that have been documented over the past thirty years, a more recent report presents the opposite finding; that a large dose of estradiol ... ...

Abstract	Apart from the well known inhibitory effects of estradiol on food intake, meal size, and body weight in female rats that have been documented over the past thirty years, a more recent report presents the opposite finding; that a large dose of estradiol can increase food intake and weight gain in gonadally intact female rats presented with a palatable diet. The purpose of the present experiment was to further examine this hypothesis by evaluating the ability of estradiol to influence feeding behavior in ovariectomized rats presented with diets that differ in flavor and fat content. Female rats were given a cyclic regimen of estradiol benzoate treatment (5.0 or 20.0 microg) or the oil vehicle and were presented with the standard chow diet or a diet with a higher fat content and chocolate flavor. Food intake, meal size, and meal number were monitored three days after the first injection of estradiol or oil. Compared to the chow diet, food intake increased when animals had access to the chocolate/fat diet during the vehicle treatment condition. Both doses of estradiol significantly decreased food intake, meal size, and body weight gain when animals were presented with either the standard chow diet or the chocolate/fat diet. These findings indicate that estradiol does not stimulate the intake of a palatable diet in ovariectomized rats, and suggest that previous results showing that estradiol enhanced eating and weight gain stemmed from a disruption of the hypothalamic-pituitary-gonadal axis when intact females received a large dose of exogenous estradiol.
MeSH term(s)	Analysis of Variance ; Animals ; Body Weight/drug effects ; Diet ; Dietary Fats/administration & dosage ; Dose-Response Relationship, Drug ; Drinking/drug effects ; Eating/drug effects ; Estradiol/pharmacology ; Estrogens/pharmacology ; Feeding Behavior/drug effects ; Female ; Flavoring Agents/pharmacology ; Food Preferences/drug effects ; Ovariectomy ; Rats ; Rats, Long-Evans
Chemical Substances	Dietary Fats ; Estrogens ; Flavoring Agents ; Estradiol (4TI98Z838E)
Language	English
Publishing date	2009-08-21
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	3907-x
ISSN	1873-507X ; 0031-9384
ISSN (online)	1873-507X
ISSN	0031-9384
DOI	10.1016/j.physbeh.2009.10.009
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Article ; Online: Monitoring plasma nucleosome concentrations to measure disease response and progression in dogs with hematopoietic malignancies.

Heather Wilson-Robles / Emma Warry / Tasha Miller / Jill Jarvis / Matthew Matsushita / Pamela Miller / Marielle Herzog / Jean-Valery Turatsinze / Theresa K Kelly / S Thomas Butera / Gaetan Michel

PLoS ONE, Vol 18, Iss 5, p e

2023 Volume 0281796

Abstract: ... multiple myeloma. Additionally, C-reactive protein and thymidine kinase-1 levels were recorded. Results Plasma ... concentrations correlated better with disease response and progression than either thymidine kinase or C reactive ... Background Hematopoietic malignancies are extremely common in pet dogs and represent nearly 30 ...

Abstract	Background Hematopoietic malignancies are extremely common in pet dogs and represent nearly 30% of the malignancies diagnosed in this population each year. Clinicians commonly use existing tools such as physical exam findings, radiographs, ultrasound and baseline blood work to monitor these patients for treatment response and remission. Circulating biomarkers, such as prostate specific antigen or carcinoembryonic antigen, can be useful tools for monitoring treatment response and remission status in human cancer patients. To date, there has a been a lack of useful circulating biomarkers available to veterinary oncology patients. Methods Circulating plasma nucleosome concentrations were evaluated at diagnosis, throughout treatment and during remission monitoring for 40 dogs with lymphoma, acute myelogenous leukemia and multiple myeloma. Additionally, C-reactive protein and thymidine kinase-1 levels were recorded. Results Plasma nucleosome concentrations were significantly higher at diagnosis and progressive disease than they were when dogs were in remission. All but two dogs had plasma nucleosome concentrations that returned to the low range during treatment. These two dogs had the shortest progression free and overall survival times. Dogs with the highest plasma nucleosome concentrations had a significantly shorter first progression free survival than dogs with lower plasma nucleosome concentrations at diagnosis. Plasma nucleosome concentrations correlated better with disease response and progression than either thymidine kinase or C reactive protein. Conclusions Plasma nucleosome concentrations can be a useful tool for treatment monitoring and disease progression in dogs with hematopoietic malignancies.
Keywords	Medicine ; R ; Science ; Q
Subject code	610 ; 630
Language	English
Publishing date	2023-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
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Article ; Online: Clonal haematopoiesis of indeterminate potential among cancer survivors exposed to myelotoxic chemotherapy.

Olszewski, Adam J / Chorzalska, Anna D / Kim, Annette S / Quesenberry, Peter J / Lopresti, Mary L / Fenton, Mary A / Reagan, John L / Butera, James N / Sahin, Ilyas / Hamel, Celine / Robison, Jordan / Petersen, Max / Dubielecka, Patrycja M

British journal of haematology

2019 Volume 186, Issue 3, Page(s) e31–e35

MeSH term(s)	Aged ; Cancer Survivors ; Clonal Evolution ; Female ; Hematopoiesis/physiology ; Humans ; Male ; Middle Aged ; Neoplasms/blood ; Neoplasms/drug therapy ; Neoplasms/genetics ; Neoplasms/mortality
Language	English
Publishing date	2019-03-11
Publishing country	England
Document type	Letter ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80077-6
ISSN	1365-2141 ; 0007-1048
ISSN (online)	1365-2141
ISSN	0007-1048
DOI	10.1111/bjh.15861
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