Filariasis Clinical Trial
Official title:
A Phase 1, Single-Blind, Randomized, Placebo Controlled, Parallel-Group, Multiple-Dose-Escalation Study to Investigate Safety, Tolerability, and Pharmacokinetics of Emodepside (BAY 44-4400) After Oral Dosing in Healthy Male Subjects
The study evaluates safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of emodepside, after administration as a Liquid Service Formulation (LSF), over 10 days, in healthy male caucasian subjects.
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 Mass Drug Administration (MDA)
programs. Emodepside is a promising candidate to kill the adult and sexually mature O.
volvulus as explained below. 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, supporting continuation of the Phase I development program. In the present repeat
dose study, PK as well as safety and tolerability of the liquid service formulation of
emodepside, given over 10 days, will be tested.
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