Safety, tolerability and PK, including food effect, of RGH-271; vA
Research type
Research Study
Full title
A single ascending dose study to evaluate the pharmacokinetic, safety and tolerability profile and the effects of food on the pharmacokinetics of RGH-271, in healthy male volunteers (HMR code: 17-010)
IRAS ID
236869
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
Gedeon Richter
Eudract number
2017-004085-97
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine (RGH-271) is an experimental treatment for certain brain diseases that affect how people think, feel or behave. We hope that the study medicine will help control some of the symptoms by attaching itself (‘binding’) to certain sites in the brain and causing changes in levels of messengers in the brain (called ‘neurotransmitters’).\n\nWe’ll test single doses of the study medicine in healthy men, aged 18–45 years, to find out its side effects, blood levels and effects on participants’ sleep. It’s never been given to humans before, so we’ll start with a small dose, and increase it as the study progresses, if that previous dose is shown to be safe. We’ll also test whether food affects blood levels of the study medicine, and if it has any effect on heart rhythm.\n\nThe study is in 2 parts (Parts 1 and 2): \n\n* In Part 1, we’ll give up to 116 participants a single dose of study medicine, in groups of 8–12. They’ll take about 6 weeks to finish the study, will make 2 outpatient visits, and stay on the ward for 4 nights in a row.\n* In Part 2, we’ll give up to 24 participants (in 2 groups of 12) 2 single doses, either after fasting or after a high-fat breakfast. They’ll take about 8 weeks to finish the study, will make 3 outpatient visits, and stay on the ward for 6 nights (across 2 study sessions). \n\nA pharmaceutical company (Gedeon Richter) is funding the study.\n\nThe study will take place at 1 centre in London.\n
REC name
HSC REC A
REC reference
17/NI/0220
Date of REC Opinion
4 Dec 2017
REC opinion
Favourable Opinion