2.2 Investigational Product (IP)
Emodepside and placebo were supplied as a liquid service formulation
(LSF) and in three different tablet formulations. The LSF was a 0.1%
(w/v) solution containing 1 mg emodepside per mL. Conventional
immediate-release (IR) tablets containing emodepside in crystalline form
were supplied in two dosage strengths, 5 and 20 mg, for the single
ascending dose (SAD) study. The tablets used in the relative
bioavailability (RBA) study were amorphous solid dispersion (ASD)
tablets containing 5 mg of emodepside in amorphous form, embedded in
either a gastroresistant polymer or a gastrosoluble polymer.
The LSF, tablets and matching placebos were developed and manufactured
by Bayer AG. Manufacturing, packaging, quality control and preparation
of clinical supplies complied with Good Manufacturing Practice.
Randomisation, using a pre‐determined randomisation list and IP
allocation, was performed by research personnel not involved in any
other study‐related activity.