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.).