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single dose

  • Open Access
    First-Time-in-Human Study and Prediction of Early Bactericidal Activity for GSK3036656, a Potent Leucyl-tRNA Synthetase Inhibitor for Tuberculosis Treatment
    Editor's Pick Clinical Therapeutics
    First-Time-in-Human Study and Prediction of Early Bactericidal Activity for GSK3036656, a Potent Leucyl-tRNA Synthetase Inhibitor for Tuberculosis Treatment

    This first-time-in-human (FTIH) study evaluated the safety, tolerability, pharmacokinetics, and food effect of single and repeat oral doses of GSK3036656, a leucyl-tRNA synthetase inhibitor. In part A, GSK3036656 single doses of 5 mg (fed and fasted), 15 mg, and 25 mg and placebo were administered. In part B, repeat doses of 5 and 15 mg and placebo were administered for 14 days once daily.

    David Tenero, Geo Derimanov, Alex Carlton, John Tonkyn, Matt Davies, Simon Cozens, Stephanie Gresham, Alison Gaudion, Adeep Puri, Morris Muliaditan, Joaquin Rullas-Trincado, Alfonso Mendoza-Losana, Andrew Skingsley, David Barros-Aguirre
  • A First-in-Human Safety, Tolerability, and Pharmacokinetics Study of Benapenem in Healthy Chinese Volunteers
    Clinical Therapeutics
    A First-in-Human Safety, Tolerability, and Pharmacokinetics Study of Benapenem in Healthy Chinese Volunteers

    The objective of this trial was to investigate the safety, tolerability, and pharmacokinetics (PK) of benapenem administered by single or multiple intravenous infusions in healthy Chinese volunteers. The trial was divided into 3 parts.

    Cai-Yun Zhao, Yuan Lv, Yan Zhu, Min-Ji Wei, Meng-Ying Liu, Xi-Wei Ji, Zi-Sheng Kang, Ya-Hong Xia, Ji-Hong Tian, Yan Ma, Yan Liu
  • Single-Dose Pharmacokinetics, Excretion, and Metabolism of Zoliflodacin, a Novel Spiropyrimidinetrione Antibiotic, in Healthy Volunteers
    Pharmacology
    Single-Dose Pharmacokinetics, Excretion, and Metabolism of Zoliflodacin, a Novel Spiropyrimidinetrione Antibiotic, in Healthy Volunteers

    Zoliflodacin is a novel spiropyrimidinetrione with activity against bacterial type II topoisomerases that inhibits DNA biosynthesis and results in accumulation of double-strand cleavages in bacteria. We report results from two phase 1 studies that investigated the safety, tolerability, and pharmacokinetics (PK) of zoliflodacin and absorption, distribution, metabolism, and excretion (ADME) after single doses in healthy volunteers.

    ...
    John O’Donnell, Ken Lawrence, Karthick Vishwanathan, Vinayak Hosagrahara, John P. Mueller
  • Clinical Therapeutics
    Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies
    G. Ralph Corey, Jeffery Loutit, Greg Moeck, Matthew Wikler, Michael N. Dudley, William O'Riordan
    and on behalf of the SOLO I and SOLO II Investigators
  • Open Access
    Pharmacology
    Pharmacological Basis of CD101 Efficacy: Exposure Shape Matters
    Elizabeth A. Lakota, Justin C. Bader, Voon Ong, Ken Bartizal, Lynn Miesel, David R. Andes, Sujata M. Bhavnani, Christopher M. Rubino, Paul G. Ambrose, Alexander J. Lepak
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