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pharmacokinetics

  • Safety, Tolerability, and Pharmacokinetics of a Novel Oral Amphotericin B Formulation (iCo-019) following Single-Dose Administration to Healthy Human Subjects: an Alternative Approach to Parenteral Amphotericin B Administration
    Pharmacology
    Safety, Tolerability, and Pharmacokinetics of a Novel Oral Amphotericin B Formulation (iCo-019) following Single-Dose Administration to Healthy Human Subjects: an Alternative Approach to Parenteral Amphotericin B Administration

    This study evaluated the safety, tolerability, and pharmacokinetics of a novel oral amphotericin B (AmB) formulation (iCo-019) following single doses to healthy humans. The data from this study suggest that iCo-019 has a long circulation time and systemic exposure without the associated gastrointestinal, liver, and kidney toxicity associated with AmB. This novel oral AmB formulation can serve as a new treatment strategy to overcome the...

    Peter Hnik, Ellen K. Wasan, Kishor M. Wasan
  • Antiretroviral Penetration and Drug Transporter Concentrations in the Spleens of Three Preclinical Animal Models and Humans
    Pharmacology
    Antiretroviral Penetration and Drug Transporter Concentrations in the Spleens of Three Preclinical Animal Models and Humans

    Adequate antiretroviral (ARV) concentrations in lymphoid tissues are critical for optimal antiretroviral therapy (ART). While the spleen contains 25% of the body’s lymphocytes, there are minimal data on ARV penetration in this organ. This study quantified total and protein-unbound splenic ARV concentrations and determined whether drug transporters, sex, or infection status were modifiers of these concentrations in animal models and...

    Aaron S. Devanathan, John K. Fallon, Nicole R. White, Amanda P. Schauer, Brian Van Horne, Kimberly Blake, Craig Sykes, Martina Kovarova, Lourdes Adamson, Leila Remling-Mulder, Paul Luciw, J. Victor Garcia, Ramesh Akkina, Jason R. Pirone, Philip C. Smith, Angela D. M. Kashuba
  • Population Pharmacokinetics of Linezolid in Tuberculosis Patients: Dosing Regimen Simulation and Target Attainment Analysis
    Clinical Therapeutics
    Population Pharmacokinetics of Linezolid in Tuberculosis Patients: Dosing Regimen Simulation and Target Attainment Analysis

    The prolonged treatment duration for multidrug-resistant tuberculosis (MDR-TB) makes linezolid dosing difficult because of adverse effects associated with long-term use. We sought to find the optimal dosing regimen for linezolid across different MIC values. Pharmacokinetic (PK) data from TB patients were included from Brazil, Georgia, and two U.S. sites. Population PK modeling and simulation were performed. We used an fAUC (...

    Wael A. Alghamdi, Mohammad H. Al-Shaer, Guohua An, Abdullah Alsultan, Maia Kipiani, Ketevan Barbakadze, Lali Mikiashvili, David Ashkin, David E. Griffith, J. Peter Cegielski, Russell R. Kempker, Charles A. Peloquin
  • Open Access
    Phase I EnACT Trial of the Safety and Tolerability of a Novel Oral Formulation of Amphotericin B
    Clinical Therapeutics
    Phase I EnACT Trial of the Safety and Tolerability of a Novel Oral Formulation of Amphotericin B

    Amphotericin B deoxycholate (AMB) has substantial toxicities. A novel encochleated amphotericin B deoxycholate (cAMB) formulation has oral bioavailability, efficacy in an animal model, and minimal toxicity due to targeted drug delivery into macrophages, where intracellular fungi reside. We conducted a phase I, ascending-dose trial of cAMB administered at 1.0 g, 1.5 g, or 2.0 g per day in 4 to 6 divided doses among HIV-positive survivors...

    Caleb P. Skipper, Mucunguzi Atukunda, Anna Stadelman, Nicole W. Engen, Ananta S. Bangdiwala, Katherine H. Hullsiek, Mahsa Abassi, Joshua Rhein, Melanie R. Nicol, Eva Laker, Darlisha A. Williams, Raphael Mannino, Theresa Matkovits, David B. Meya, David R. Boulware
  • Safety and Pharmacokinetics of Recombinant Human Plasma Gelsolin in Patients Hospitalized for Nonsevere Community-Acquired Pneumonia
    Clinical Therapeutics
    Safety and Pharmacokinetics of Recombinant Human Plasma Gelsolin in Patients Hospitalized for Nonsevere Community-Acquired Pneumonia

    There remains an unmet need to address the substantial morbidity and mortality associated with severe community-acquired pneumonia (sCAP). Recombinant human plasma gelsolin (rhu-pGSN) improves disease outcomes in diverse animal models of infectious and noninfectious inflammation. This blinded dose-escalation safety study involved non-intensive care unit (ICU) patients admitted for mild CAP and randomized 3:1 to receive adjunctive rhu-...

    Abla Tannous, Susan L. Levinson, James Bolognese, Steven M. Opal, Mark J. DiNubile
  • Characterization of Amikacin Drug Exposure and Nephrotoxicity in an Animal Model
    Experimental Therapeutics
    Characterization of Amikacin Drug Exposure and Nephrotoxicity in an Animal Model

    Despite excellent in vitro activity, aminoglycosides are used conservatively to treat multidrug-resistant bacterial infections due to their associated nephrotoxicity. Aminoglycosides are known to accumulate in the kidneys, but the quantitative relationship between drug exposures and nephrotoxicity is not well established. To bridge the knowledge gap, the objective of this study was to develop an animal model with clinically...

    Katrina Chan, Kimberly R. Ledesma, Weiqun Wang, Vincent H. Tam
  • Open Access
    Caspofungin Weight-Based Dosing Supported by a Population Pharmacokinetic Model in Critically Ill Patients
    Pharmacology
    Caspofungin Weight-Based Dosing Supported by a Population Pharmacokinetic Model in Critically Ill Patients

    The objective of this study was to develop a population pharmacokinetic model and to determine a dosing regimen for caspofungin in critically ill patients. Nine blood samples were drawn per dosing occasion. Fifteen patients with (suspected) invasive candidiasis had one dosing occasion and five had two dosing occasions, measured on day 3 (±1) of treatment. Pmetrics was used for population pharmacokinetic modeling and probability of...

    Anne-Grete Märtson, Kim C. M. van der Elst, Anette Veringa, Jan G. Zijlstra, Albertus Beishuizen, Tjip S. van der Werf, Jos G. W. Kosterink, Michael Neely, Jan-Willem Alffenaar
  • Open Access
    Population Pharmacokinetics of Praziquantel in Pregnant and Lactating Filipino Women Infected with <span class="named-content genus-species" id="named-content-1">Schistosoma japonicum</span>
    Pharmacology
    Population Pharmacokinetics of Praziquantel in Pregnant and Lactating Filipino Women Infected with Schistosoma japonicum

    An estimated 40 million women of reproductive age are infected with one of three species of the waterborne parasite Schistosoma spp. Treatment with praziquantel (PZQ) via mass drug administration (MDA) campaigns is the mainstay of schistosomiasis control for populations living in areas of endemicity. The World Health Organization recommends that pregnant and lactating women be included in schistosomiasis MDA programs, and...

    Amaya L. Bustinduy, Ruwanthi Kolamunnage-Dona, Mark H. Mirochnick, Edmund V. Capparelli, Veronica Tallo, Luz P. Acosta, Remigio M. Olveda, Jennifer F. Friedman, William W. Hope
  • Ethionamide Population Pharmacokinetic Model and Target Attainment in Multidrug-Resistant Tuberculosis
    Clinical Therapeutics
    Ethionamide Population Pharmacokinetic Model and Target Attainment in Multidrug-Resistant Tuberculosis

    Ethionamide (ETA), an isonicotinic acid derivative, is part of the multidrug-resistant tuberculosis (MDR-TB) regimen. The current guidelines have deprioritized ETA because it is potentially less effective than other agents. Our aim was to develop a population pharmacokinetic (PK) model and simulate ETA dosing regimens in order to assess target attainment. This study included subjects from four different sites, including healthy...

    Mohammad H. Al-Shaer, Anne-Grete Märtson, Wael A. Alghamdi, Abdullah Alsultan, Guohua An, Shahriar Ahmed, Yosra Alkabab, Sayera Banu, Eric R. Houpt, David Ashkin, David E. Griffith, J. Peter Cegielski, Scott K. Heysell, Charles A. Peloquin
  • Open Access
    Safety, Pharmacokinetics, and Activity of High-Dose Ivermectin and Chloroquine against the Liver Stage of <span class="named-content genus-species" id="named-content-1">Plasmodium cynomolgi</span> Infection in Rhesus Macaques
    Pharmacology
    Safety, Pharmacokinetics, and Activity of High-Dose Ivermectin and Chloroquine against the Liver Stage of Plasmodium cynomolgi Infection in Rhesus Macaques

    Previously, ivermectin (1 to 10 mg/kg of body weight) was shown to inhibit the liver-stage development of Plasmodium berghei in orally dosed mice. Here, ivermectin showed inhibition of the in vitro development of Plasmodium cynomolgi schizonts (50% inhibitory concentration [IC50...

    Pattaraporn Vanachayangkul, Rawiwan Im-erbsin, Anchalee Tungtaeng, Chanikarn Kodchakorn, Alison Roth, John Adams, Chaiyaporn Chaisatit, Piyaporn Saingam, Richard J. Sciotti, Gregory A. Reichard, Christina K. Nolan, Brandon S. Pybus, Chad C. Black, Luis A. Lugo-Roman, Matthew D. Wegner, Philip L. Smith, Mariusz Wojnarski, Brian A. Vesely, Kevin C. Kobylinski

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