Emodepside - first doses in humans, v1
Research type
Research Study
Full title
A Phase 1, Blinded, Randomized, Placebo-Controlled, Parallel-Group, Single-Dose, Dose-Escalation Study to Investigate Safety, Tolerability, and Pharmacokinetics of Emodepside (BAY 44-4400) After Oral Dosing in Healthy Male Subjects. HMR code (15-020)
IRAS ID
187329
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
Drugs for Neglected Diseases initiative (DNDi)
Eudract number
2015-003592-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
The study medicine is a licensed treatment for cats and dogs infected with worms. We want to find out if it can be used to treat a disease in humans called river blindness.
River blindness is caused by a worm called Onchocerca volvulus. It infects many people in West and Central Africa. River blindness is an eye and skin disease. It causes severe itching and skin problems, such as changes in pigmentation, and some people develop visual impairment, which can lead to blindness. We hope that the study medicine will work better, and have fewer side effects, than the existing treatments.
We’ll give healthy volunteers single doses of the study medicine. It’s never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. We aim to find out its side effects and blood levels, and how long it takes for the body to get rid of it when it's taken in tablet and liquid forms.
We’ll give 72 healthy men, aged 18–55 years, single doses. We’ll start with a low dose, and increase the dose as the study progresses.
Each participant will have a screening visit. Then they will stay on the ward for 9 nights in a row, and make 1 outpatient visit. For some groups, we might ask participants to stay for 7 extra nights, or make 4 extra outpatient visits, depending on the results from previous groups.
Participants will take up to 7 weeks to finish the study.
A not-for-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 B
REC reference
15/NI/0195
Date of REC Opinion
20 Oct 2015
REC opinion
Favourable Opinion