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.