2.1 General
The study designs are presented in Table 1. The initial doses were selected based on the predicted human PK and therapeutic dose, derived from data obtained from in vitro and in vivo studies after administration of emodepside to rats and dogs, and from in vitrodata on plasma-protein binding and blood-plasma partitioning.13
The three studies were approved by local research ethics committees in the United Kingdom and were conducted in compliance with the Declaration of Helsinki and the International Conference on Harmonisation E6 Guideline for Good Clinical Practice. A clinical trial authorisation was obtained from the Medicines and Healthcare products Regulatory Agency (U.K.) for each study. The studies were registered at clinicaltrials.gov and in EudraCT. Written informed consent was obtained from all subjects before undertaking any study-related procedures. Quality assurance, data management and study monitoring were performed by contract research organisations (Hammersmith Medicines Research, London U.K. and Niche Science and Technology, Richmond U.K.).