Literature DB >> 26883693

Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.

Daniel Gonzalez1, Debra L Palazzi2, Leena Bhattacharya-Mithal3, Amira Al-Uzri4, Laura P James5, John Bradley6, Natalie Neu7, Theresa Jasion8, Christoph P Hornik9, P Brian Smith9, Daniel K Benjamin9, Kara Keedy10, Prabhavathi Fernandes10, Michael Cohen-Wolkowiez11.   

Abstract

We assessed the pharmacokinetics and safety of solithromycin, a fluoroketolide antibiotic, in a phase 1, open-label, multicenter study of 13 adolescents with suspected or confirmed bacterial infections. On days 3 to 5, the mean (standard deviation) maximum plasma concentration and area under the concentration versus time curve from 0 to 24 h were 0.74 μg/ml (0.61 μg/ml) and 9.28 μg · h/ml (6.30 μg · h/ml), respectively. The exposure and safety in this small cohort of adolescents were comparable to those for adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01966055.).
Copyright © 2016, American Society for Microbiology. All Rights Reserved.

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Year:  2016        PMID： 26883693      PMCID： PMC4808196          DOI： 10.1128/AAC.02561-15

Source DB:  PubMed          Journal:  Antimicrob Agents Chemother        ISSN： 0066-4804            Impact factor:   5.938


  14 in total

1.  Pharmacokinetics of azithromycin after single- and multiple-doses in children.

Authors:  R C Stevens; M D Reed; J L Shenep; D K Baker; G Foulds; D R Luke; J L Blumer; J H Rodman
Journal:  Pharmacotherapy       Date:  1997 Sep-Oct       Impact factor: 4.705

2.  Safety and Pharmacokinetics of Solithromycin in Subjects with Hepatic Impairment.

Authors:  Brian D Jamieson; Sabrina Ciric; Prabhavathi Fernandes
Journal:  Antimicrob Agents Chemother       Date:  2015-04-13       Impact factor: 5.191

3.  Pharmacokinetics of solithromycin (CEM-101) after single or multiple oral doses and effects of food on single-dose bioavailability in healthy adult subjects.

Authors:  J Gordon Still; Jennifer Schranz; Thorsten P Degenhardt; Drusilla Scott; Prabhavathi Fernandes; Maria J Gutierrez; Kay Clark
Journal:  Antimicrob Agents Chemother       Date:  2011-01-31       Impact factor: 5.191

Review 4.  Drug disposition in cystic fibrosis.

Authors:  E Rey; J M Tréluyer; G Pons
Journal:  Clin Pharmacokinet       Date:  1998-10       Impact factor: 6.447

5.  Quantification of rifapentine, a potent antituberculosis drug, from dried blood spot samples using liquid chromatographic-tandem mass spectrometric analysis.

Authors:  Teresa L Parsons; Mark A Marzinke; Thuy Hoang; Erin Bliven-Sizemore; Marc Weiner; William R Mac Kenzie; Susan E Dorman; Kelly E Dooley
Journal:  Antimicrob Agents Chemother       Date:  2014-09-02       Impact factor: 5.191

6.  Determining population and developmental pharmacokinetics of metronidazole using plasma and dried blood spot samples from premature infants.

Authors:  Michael Cohen-Wolkowiez; Mario Sampson; Barry T Bloom; Antonio Arrieta; James L Wynn; Karen Martz; Barrie Harper; Gregory L Kearns; Edmund V Capparelli; David Siegel; Daniel K Benjamin; P Brian Smith
Journal:  Pediatr Infect Dis J       Date:  2013-09       Impact factor: 2.129

7.  A comprehensive in vitro and in silico analysis of antibiotics that activate pregnane X receptor and induce CYP3A4 in liver and intestine.

Authors:  Kazuto Yasuda; Aarati Ranade; Raman Venkataramanan; Stephen Strom; Jonathan Chupka; Sean Ekins; Erin Schuetz; Kenneth Bachmann
Journal:  Drug Metab Dispos       Date:  2008-05-27       Impact factor: 3.922

8.  Bioavailability and population pharmacokinetics of voriconazole in lung transplant recipients.

Authors:  Kelong Han; B Capitano; R Bies; B A Potoski; S Husain; S Gilbert; D L Paterson; K McCurry; R Venkataramanan
Journal:  Antimicrob Agents Chemother       Date:  2010-08-02       Impact factor: 5.191

9.  Pharmacodynamic analysis of the microbiological efficacy of telithromycin in patients with community-acquired pneumonia.

Authors:  Jun Shi; Marc Pfister; Stephen G Jenkins; Sunny Chapel; Jeffrey S Barrett; Ruedi E Port; Dan Howard
Journal:  Clin Pharmacokinet       Date:  2005       Impact factor: 5.577

10.  Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots.

Authors:  Daniel Gonzalez; Chiara Melloni; Brenda B Poindexter; Ram Yogev; Andrew M Atz; Janice E Sullivan; Susan R Mendley; Paula Delmore; Amy Delinsky; Kanecia Zimmerman; Andrew Lewandowski; Barrie Harper; Kenneth C Lewis; Daniel K Benjamin; Michael Cohen-Wolkowiez
Journal:  Bioanalysis       Date:  2015       Impact factor: 2.695
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  8 in total

1.  Efficacy of Solithromycin (CEM-101) for Experimental Otitis Media Caused by Nontypeable Haemophilus influenzae and Streptococcus pneumoniae.

Authors:  M Figueira; P Fernandes; S I Pelton
Journal:  Antimicrob Agents Chemother       Date:  2016-08-22       Impact factor: 5.191

Review 2.  Solithromycin: A Novel Fluoroketolide for the Treatment of Community-Acquired Bacterial Pneumonia.

Authors:  George G Zhanel; Erika Hartel; Heather Adam; Sheryl Zelenitsky; Michael A Zhanel; Alyssa Golden; Frank Schweizer; Bala Gorityala; Philippe R S Lagacé-Wiens; Andrew J Walkty; Alfred S Gin; Daryl J Hoban; Joseph P Lynch; James A Karlowsky
Journal:  Drugs       Date:  2016-12       Impact factor: 9.546

3.  Solithromycin in Children and Adolescents With Community-acquired Bacterial Pneumonia.

Authors:  Jason E Lang; Christoph P Hornik; Carrie Elliott; Adam Silverstein; Chi Hornik; Amira Al-Uzri; Miroslava Bosheva; John S Bradley; Charissa Fay Corazon Borja-Tabora; David Di John; Ana Mendez Echevarria; Jessica E Ericson; David Friedel; Ferenc Gonczi; Marie Grace Dawn Isidro; Laura P James; Krisztina Kalocsai; Ioannis Koutroulis; Istvan Laki; Anna Lisa T Ong-Lim; Marta Nad; Gabor Simon; Salma Syed; Eva Szabo; Daniel K Benjamin; Michael Cohen-Wolkowiez
Journal:  Pediatr Infect Dis J       Date:  2022-06-07       Impact factor: 3.806

4.  Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents.

Authors:  Daniel Gonzalez; Laura P James; Amira Al-Uzri; Miroslava Bosheva; Felice C Adler-Shohet; Susan R Mendley; John S Bradley; Claudia Espinosa; Eva Tsonkova; Kathryn Moffett; Lucila Marquez; Kari A Simonsen; Stefan Stoilov; Felix Boakye-Agyeman; Theresa Jasion; Christoph P Hornik; Robert Hernandez; Daniel K Benjamin; Michael Cohen-Wolkowiez
Journal:  Antimicrob Agents Chemother       Date:  2018-07-27       Impact factor: 5.191

5.  A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication.

Authors:  Ryan J Beechinor; Michael Cohen-Wolkowiez; Theresa Jasion; Christoph P Hornik; Jason E Lang; Robert Hernandez; Daniel Gonzalez
Journal:  Ther Drug Monit       Date:  2019-12       Impact factor: 3.118

Review 6.  Spotlight on solithromycin in the treatment of community-acquired bacterial pneumonia: design, development, and potential place in therapy.

Authors:  Bryan J Donald; Salim Surani; Harmeet S Deol; Uche J Mbadugha; George Udeani
Journal:  Drug Des Devel Ther       Date:  2017-12-13       Impact factor: 4.162

Review 7.  Nature nurtures the design of new semi-synthetic macrolide antibiotics.

Authors:  Prabhavathi Fernandes; Evan Martens; David Pereira
Journal:  J Antibiot (Tokyo)       Date:  2016-11-30       Impact factor: 2.649

8.  Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates.

Authors:  Jennifer Le; Brenda Poindexter; Janice E Sullivan; Matthew Laughon; Paula Delmore; Martha Blackford; Ram Yogev; Laura P James; Chiara Melloni; Barrie Harper; Jeff Mitchell; Daniel K Benjamin; Felix Boakye-Agyeman; Michael Cohen-Wolkowiez
Journal:  Ther Drug Monit       Date:  2018-02       Impact factor: 3.118
  8 in total

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