Emodepside – repeat doses in humans; version 1
Research type
Research Study
Full 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 (HMR code: 16-021)
IRAS ID
233698
Contact name
Jeremy Dennison
Contact email
Sponsor organisation
Drugs for Neglected Diseases initiative (DNDi)
Eudract number
2017-003020-75
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
The study medicine 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, can have serious side effects. We hope emodepside will attack the adult worms, need a shorter treatment time, and have fewer side effects, than existing treatments.\n\nWe’ll give healthy volunteers repeated doses of emodepside, as a liquid, to find out its side effects and blood levels, and if it causes any diabetes-like effects in the body. \n\nWe’ll give 24 healthy white men, aged 18–55 years, once- or twice-daily doses of emodepside for 10 days. We’ll start with a low dose, and increase the dose as the study progresses, depending on the results from previous groups. Some participants will take dummy medicine instead of the study medicine. Neither the participants nor we will know which treatment they’re taking.\n\nWe’ll study the participants in 3 groups of 8 volunteers. Each participant will have 2 screening visits, including a visit to a specialist eye clinic. Then they’ll stay on the ward for 17 nights in a row, and make 5 outpatient visits.\n\nParticipants will take up to 9 weeks to finish the study.\n\nA not-for-profit organisation (Drugs for Neglected Diseases initiative – DNDi) is the sponsor of the study.\n\nThe study will take place at 1 centre in London.\n
REC name
London - Harrow Research Ethics Committee
REC reference
17/LO/1452
Date of REC Opinion
19 Oct 2017
REC opinion
Further Information Favourable Opinion