Filariasis Clinical Trial
Official title:
Phase1,Randomized,Open-Label,Parallel-Group,Relative Bioavailability Study to Investigate PK,Including Food Effect,Safety and Tolerability of Single Doses of New Immediate Release Tablet Formulations of Emodepside (BAY 44-4400),Compared to Oral Solution,in Healthy Male Subjects
This study evaluates 2 new immediate release (IR)-tablet formulations of emodepside and they will be compared to the oral liquid service formulation (LSF) used in the FIH Single Ascending Dose study (DNDi-EMO-001 study) (CT.gov identifier: NCT02661178)
There is an urgent need for a macrofilaricidal drug, killing or sterilizing permanently O.
volvulus adult worms, which could be used in individual case management and, after
appropriate testing, as an alternative drug to ivermectin in MDA programs. Emodepside is a
promising candidate to kill the adult and sexually mature O. volvulus. Emodepside was shown
to be macrofilaricidal against a variety of filarial nematodes and is a registered drug for
animal health, commercialized by Bayer AG under the name of Profender® (in combination with
praziquantel) or Procox® (in combination with toltrazuril).
A first-in-human (FIH) double-blind, placebo-controlled study of single ascending doses of
emodepside in healthy Caucasian men has been conducted and the preliminary results are
favourable, and support continuing the Phase I development program. For this reason, new
tablet formulations have been developped and the present study will evaluate bioavailability,
PK safety and tolerability, and as well food effect of single doses of 2 new immediate
release (IR)-tablet formulations of emodepside compared to the oral liquid service
formulation (LSF) used in the FIH study.
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