Comparing blood levels after different forms of emodepside; version 1
Research type
Research Study
Full title
A Phase 1, Randomized, Open-Label, Parallel-Group, Relative Bioavailability Study to Investigate the Pharmacokinetics, including Food Effect, as well as the 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 (HMR code: 17-008)
IRAS ID
233707
Contact name
Jeremy Dennison
Contact email
Sponsor organisation
Drugs for Neglected Diseases initiative (DNDi)
Eudract number
2017-003091-31
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
The study medicine (emodepside) is a licensed treatment for cats and dogs infected with worms. Emodepside could be a potential new treatment for river blindness, which is an eye and skin disease caused by a worm that mainly affects people in West and Central Africa. Current treatments for river blindness kill the immature worms (larvae) but don’t get rid of the adult worms. So those treatments must be taken for up to 15 years, and in rare cases, have serious side effects. We hope that emodepside will attack the adult worms, need a shorter treatment time, and have fewer side effects, than the existing treatments.
In this 2-part study, we’ll compare 2 new tablet forms of emodepside with an existing liquid form. We aim to find out the side effects and blood levels after a dose of tablets, and compare them to emodepside when it's taken as a liquid. We’ll also test whether food affects blood levels of the study medicine.
We’ll give 84 healthy men, aged 18–45 years, single doses of emodepside. In Part 1, we’ll give 5 mg after an overnight fast or after a fatty breakfast; in Part 2, we’ll give 10 mg after an overnight fast (as two 5 mg tablets). Each participant will have a screening visit. Then they’ll stay on the ward for 4 nights in a row, and make 2 outpatient visits.
Participants will take about 5 weeks to finish the study.
A non-profit organisation (Drugs for Neglected Diseases initiative – DNDi) is the sponsor of the study.
The study will take place at 1 centre in London.
REC name
HSC REC A
REC reference
17/NI/0171
Date of REC Opinion
24 Oct 2017
REC opinion
Further Information Favourable Opinion