Determine the bioequivalence of the selected paediatric formulation with the approved 2 mg tablet formulation in clinical study in Ghana

The primary objective of WP4 and this clinical study is to determine the bioequivalence of the paediatric formulation of moxidectin with moxidectin 2 mg tablets through a clinical study comparing plasma pharmacokinetic parameters in volunteers in Ghana.

A Clinical Project Team will be established by MDGH to work collaboratively with Principal Investigator Dr Nicholas Opoku and his unit at the University of Health and Allied Sciences in Hohoe.  The Project Team will include experts from chemistry, manufacturing and controls (CMC), statistics, pharmacokinetics, project management, regulatory affairs, and clinical operations to supplement the expertise of Dr Opoku and his team. This work package will also provide capacity building opportunities for UHAS students and researchers from the Laboratory of Prof. Kamgno.

The study will be conducted in compliance with International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH) Good Clinical Practice (GCP). Although this will be one of the first bioequivalence studies to be conducted in Africa, Principal Investigator (Dr. Nicholas Opoku) is experienced in conducting clinical studies with extensive pharmacokinetic testing.

Following Ghanaian ethics and regulatory authority approval and ethical approval by a committee in an EU Member State, participants aged 18 to 65 years of age (inclusive) will be consented, screened and, if eligible, randomised to receive a single 8 mg dose of moxidectin per oral either as 2 mg tablets or as the paediatric formulation. Safety and pharmacokinetic data will be obtained post-treatment with an appropriate follow up to determine bioequivalence of the formulations. Due to the long human plasma terminal half-life of moxidectin, a parallel rather than a cross over design will be used. Conduct of the study in adults rather than a paediatric population is planned since ethical guidelines require studies to be conducted in adults, unless information valid for application to children cannot be obtained in adults. Data available on the absorption, distribution, metabolism and excretion of moxidectin do not suggest that bioavailability will be different in adults when compared to children.