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  1. Article ; Online: Hepatic Dysfunction Quantified by HepQuant DuO Outperforms Child-Pugh Classification in Predicting the Pharmacokinetics of Ampreloxetine.

    Kanodia, Jitendra / Giovinazzo, Hugh / Yates, Wayne / Bourdet, David L / McRae, Michael P / Helmke, Steve M / Everson, Gregory T

    Clinical pharmacology and therapeutics

    2024  

    Abstract: HepQuant tests quantify liver function from clearance of deuterium- and 13C-labeled cholates administered either intravenously and orally (SHUNT) or orally (DuO). Hepatic impairment studies have relied on clinical or laboratory criteria like Child-Pugh ... ...

    Abstract HepQuant tests quantify liver function from clearance of deuterium- and 13C-labeled cholates administered either intravenously and orally (SHUNT) or orally (DuO). Hepatic impairment studies have relied on clinical or laboratory criteria like Child-Pugh classification to categorize the degree of hepatic dysfunction. We compared HepQuant tests with Child-Pugh classification in predicting the pharmacokinetics of ampreloxetine. Twenty-one subjects with hepatic impairment (8 Child-Pugh A, 7 Child-Pugh B, and 6 Child-Pugh C), and 10 age- and sex-matched controls were studied. The pharmacokinetics of ampreloxetine were measured after oral administration of a single dose of 10 mg. Disease severity index (DSI), portal-systemic shunting (SHUNT%), hepatic reserve, and hepatic filtration rates (HFRs) were measured from serum samples obtained after intravenous administration of [24-
    Language English
    Publishing date 2024-04-23
    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.3265
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 20: 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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  2. Article ; Online: Pharmacodynamics, pharmacokinetics and safety of revefenacin (TD-4208), a long-acting muscarinic antagonist, in patients with chronic obstructive pulmonary disease (COPD): Results of two randomized, double-blind, phase 2 studies.

    Quinn, Dean / Barnes, Christopher N / Yates, Wayne / Bourdet, David L / Moran, Edmund J / Potgieter, Peter / Nicholls, Andrew / Haumann, Brett / Singh, Dave

    Pulmonary pharmacology & therapeutics

    2017  Volume 48, Page(s) 71–79

    Abstract: Background: Revefenacin (TD-4208) is a potent, lung-selective, long-acting muscarinic antagonist currently in development as a once-daily nebulized therapy for chronic obstructive pulmonary disease (COPD). We evaluated the pharmacodynamics ( ... ...

    Abstract Background: Revefenacin (TD-4208) is a potent, lung-selective, long-acting muscarinic antagonist currently in development as a once-daily nebulized therapy for chronic obstructive pulmonary disease (COPD). We evaluated the pharmacodynamics (bronchodilator activity), pharmacokinetics (PK) and safety of single- and multiple-dose administrations of revefenacin in two clinical trials (Study 0059 and Study 0091) in patients with moderate to severe COPD.
    Methods: In Study 0059, 32 patients were randomized to receive a single dose of revefenacin (350 or 700 μg), active control ipratropium (500 μg) or placebo inhalation solution administered via standard jet nebulizer in a double-blind, crossover fashion. In Study 0091, 59 patients were randomized to receive once-daily inhalations of revefenacin (22, 44, 88, 175, 350 or 700 μg) or placebo for 7 days in a double-blind, incomplete block, five-way crossover design. The primary efficacy endpoint was change from baseline in peak (0-6 h) forced expiratory volume in 1 s (FEV
    Results: Revefenacin demonstrated a rapid onset and sustained duration of bronchodilator action in both studies. In Study 0059, mean peak FEV
    Conclusions: Following single or multiple nebulized-dose administration in patients with COPD, revefenacin demonstrates a rapid onset and sustained duration of bronchodilator effect over 24 h following once-daily administration, with a PK profile that is commensurate with low systemic exposure.
    MeSH term(s) Administration, Inhalation ; Aged ; Benzamides/administration & dosage ; Benzamides/adverse effects ; Benzamides/pharmacokinetics ; Bronchodilator Agents/administration & dosage ; Bronchodilator Agents/adverse effects ; Bronchodilator Agents/pharmacokinetics ; Carbamates/administration & dosage ; Carbamates/adverse effects ; Carbamates/pharmacokinetics ; Cross-Over Studies ; Double-Blind Method ; Female ; Forced Expiratory Volume ; Humans ; Ipratropium/therapeutic use ; Male ; Middle Aged ; Muscarinic Antagonists/administration & dosage ; Muscarinic Antagonists/adverse effects ; Muscarinic Antagonists/pharmacokinetics ; Nebulizers and Vaporizers ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Spirometry ; Time Factors
    Chemical Substances Benzamides ; Bronchodilator Agents ; Carbamates ; Muscarinic Antagonists ; biphenyl-2-ylcarbamic acid 1-(2-((4-(4-carbamoylpiperidin-1-ylmethyl)benzoyl)methylamino)ethyl)piperidin-4-yl ester ; Ipratropium (GR88G0I6UL)
    Language English
    Publishing date 2017-10-04
    Publishing country England
    Document type Clinical Trial, Phase II ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 1399707-5
    ISSN 1522-9629 ; 1094-5539
    ISSN (online) 1522-9629
    ISSN 1094-5539
    DOI 10.1016/j.pupt.2017.10.003
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 2389: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  3. Article: Pharmacokinetics, pharmacodynamics, and safety assessment of palifermin (rHuKGF) in healthy volunteers.

    Zia-Amirhosseini, Parnian / Salfi, Margaret / Leese, Philip / Yates, Wayne / Danilenko, Dimitry M / Ring, Brian / Cesano, Alessandra / Sullivan, John T

    Clinical pharmacology and therapeutics

    2006  Volume 79, Issue 6, Page(s) 558–569

    Abstract: Background: Palifermin is a recombinant human keratinocyte growth factor approved to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies who received myelotoxic therapy requiring hematopoietic stem cell ...

    Abstract Background: Palifermin is a recombinant human keratinocyte growth factor approved to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies who received myelotoxic therapy requiring hematopoietic stem cell support.
    Methods: This randomized, double-blind, placebo-controlled study investigated the pharmacokinetics, pharmacodynamics, and safety of palifermin in healthy volunteers after single, escalating doses (60 to 250 mug/kg). Pharmacodynamic measurements (Ki67 staining) assessing buccal mucosal epithelial proliferation were performed at baseline and at 48 or 72 hours after dosing.
    Results: Exposure to palifermin increased approximately dose proportionally, with a 3-fold increase observed for a 4-fold increase in dose. Palifermin concentrations decreased sharply during the first 0.5 to 1.5 hours after dosing, slightly increased or plateaued between 1.5 and 6 hours, and subsequently decreased. The overall mean systemic clearance and volume of distribution at steady state were 590 mL/h/kg and 2000 mL/kg, respectively. The mean half-life ranged from 4.5 to 6 hours across the dose levels. The mean and SD ratio of Ki67 staining at 48 hours after dosing to baseline was 1.19 (0.24) for placebo, 2.02 (0.60) for 60 mug/kg, 3.04 (1.13) for 120 mug/kg, and 4.66 (0.77) for 250 mug/kg-treated groups.
    Conclusion: Palifermin exhibited linear pharmacokinetics and caused dose-dependent epithelial proliferation.
    MeSH term(s) Adolescent ; Adult ; Aged ; Cell Proliferation/drug effects ; Dose-Response Relationship, Drug ; Double-Blind Method ; Epithelial Cells/drug effects ; Female ; Fibroblast Growth Factor 7/administration & dosage ; Fibroblast Growth Factor 7/blood ; Fibroblast Growth Factor 7/pharmacokinetics ; Fibroblast Growth Factor 7/pharmacology ; Humans ; Injections, Intravenous ; Male ; Mouth Mucosa/cytology ; Stomatitis/drug therapy
    Chemical Substances Fibroblast Growth Factor 7 (126469-10-1)
    Language English
    Publishing date 2006-06
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 123793-7
    ISSN 1532-6535 ; 0009-9236
    ISSN (online) 1532-6535
    ISSN 0009-9236
    DOI 10.1016/j.clpt.2006.02.011
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 20: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  4. Article: Once-monthly administration of darbepoetin alfa for the treatment of patients with chronic heart failure and anemia: a pharmacokinetic and pharmacodynamic investigation.

    Cleland, John G F / Sullivan, John T / Ball, Stephen / Horowitz, John D / Agoram, Balaji / Rosser, Dylan / Yates, Wayne / Tin, Lwin / Fuentealba, Paulina / Burton, Paul B J

    Journal of cardiovascular pharmacology

    2004  Volume 46, Issue 2, Page(s) 155–161

    Abstract: In patients with chronic heart failure (CHF), anemia is associated with more severe symptoms and worse prognosis. Erythropoiesis-stimulating proteins (ESPs) increase hemoglobin and may be of therapeutic benefit. We investigated the pharmacokinetics and ... ...

    Abstract In patients with chronic heart failure (CHF), anemia is associated with more severe symptoms and worse prognosis. Erythropoiesis-stimulating proteins (ESPs) increase hemoglobin and may be of therapeutic benefit. We investigated the pharmacokinetics and pharmacodynamics of the long-acting ESP, darbepoetin alfa, administered on 2 occasions 1 month apart to 30 healthy subjects and 33 patients with symptomatic CHF and anemia (hemoglobin<or=12.5 g/dL) in 2 randomized, double-blind, placebo-controlled studies. Subcutaneous (SC) and intravenous administration of 0.75 microg/kg of darbepoetin alfa were compared in a crossover study. The second study compared 2.0, 3.0, and 5.0 microg/kg SC doses with placebo. Darbepoetin alfa (0.75 microg/kg SC) pharmacokinetics were similar in CHF patients and healthy subjects, with a mean (+/-SD) bioavailability of 29 (+/-11)% and 37 (+/-8)%, respectively. In anemic CHF patients, mean (+/-SD) increases in hemoglobin at 4 weeks after the second monthly dose of 2.0, 3.0, and 5.0 microg/kg (SC) of darbepoetin alfa were 2.3 (+/-0.6), 1.4 (+/-1.0), and 2.4 (+/-1.9) g/dL, respectively. Darbepoetin alfa 0.75 microg/kg (SC) given twice, 1 month apart, was insufficient to increase hemoglobin in this study. No severe, drug-related adverse events occurred. Darbepoetin alfa administered once monthly elevates and maintains the hemoglobin concentration in patients with CHF and anemia.<br />
    MeSH term(s) Aged ; Anemia/blood ; Anemia/complications ; Anemia/drug therapy ; Biological Availability ; Cardiac Output, Low/blood ; Cardiac Output, Low/complications ; Cardiac Output, Low/drug therapy ; Chronic Disease ; Cross-Over Studies ; Darbepoetin alfa ; Double-Blind Method ; Drug Administration Schedule ; Erythropoietin/administration & dosage ; Erythropoietin/analogs & derivatives ; Erythropoietin/pharmacokinetics ; Erythropoietin/pharmacology ; Erythropoietin/therapeutic use ; Female ; Hemoglobins/analysis ; Humans ; Injections, Intravenous ; Injections, Subcutaneous ; Male ; Middle Aged
    Chemical Substances Hemoglobins ; Erythropoietin (11096-26-7) ; Darbepoetin alfa (15UQ94PT4P)
    Language English
    Publishing date 2004-06-14
    Publishing country United States
    Document type Clinical Trial ; Clinical Trial, Phase I ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 391970-5
    ISSN 1533-4023 ; 0160-2446
    ISSN (online) 1533-4023
    ISSN 0160-2446
    DOI 10.1097/01.fjc.0000167013.77092.c4
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 1471: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    Jg. 1995 - 2021: Lesesall (1.OG)
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