PK, safety and tolerability of RGH-271 in multiple ascending doses.
Research type
Research Study
Full title
A multiple ascending dose study to evaluate the pharmacokinetic, safety and tolerability profile of RGH-271 in healthy volunteers.
IRAS ID
259403
Contact name
Denisa Wilkes
Contact email
Sponsor organisation
Gedeon Richter Plc
Eudract number
2018-004541-16
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
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’)
We’ll test repeated doses of the study medicine in up to 48 healthy men and women, aged 18–45, to find out its side effects and blood levels. We’ll also test whether the study medicine has any effect on heart rhythm, brain activity and sleeping patterns.
Participants will receive daily doses of the study medicine for 10 days. They’ll be divided in up to 6 groups of 8 volunteers. We’ll start with a low dose in the first group and increase the dose as the study progresses, if the previous dose is shown to be safe.
Participants will take up to 7 weeks to finish the study. They’ll make 3 outpatient visits, and stay on the ward for 13 nights.
A pharmaceutical company (Gedeon Richter Plc.) is funding the study.
The study will take place at 1 centre in London.
Summary of Results
This was a Phase 1 trial in healthy volunteers with no therapeutic intent. For reasons of commercial confidentiality, a lay summary of the trial results is not provided.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0068
Date of REC Opinion
6 Mar 2019
REC opinion
Further Information Favourable Opinion