Pharmacokinetics and Antiviral Activity of Phx1766, a Novel HCV Protease Inhibitor, Using An Accelerated Phase I Study Design

  title={Pharmacokinetics and Antiviral Activity of Phx1766, a Novel HCV Protease Inhibitor, Using An Accelerated Phase I Study Design},
  author={Daphne M. Hotho and Joep de Bruijne and A Marie O'Farrell and Teresa Boyea and Jianke Li and Michele Bracken and Xin Li and David Campbell and H P Guler and Christine J. Weegink and Janke Schinkel and Richard Molenkamp and Jeroen van de Wetering de Rooij and Andr{\'e} A. van Vliet and Harry L.A. Janssen and Robert J. de Knegt and Hendrik W Reesink},
  journal={Antiviral Therapy},
  pages={365 - 375}
Background PHX1766 is a novel HCV NS3/4 protease inhibitor with robust potency and high selectivity in replicon studies (50% maximal effective concentration 8 nM). Two clinical trials investigated the safety, tolerability, pharmacokinetics and antiviral activity of PHX1766 in healthy volunteers (HV) and chronic hepatitis C patients, by use of a dose-adaptive overlapping clinical trial design. Methods Two randomized, double-blind, placebo-controlled clinical trials were conducted. Single doses… 

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