*A trial to evaluate the effect of LEO 152020 on the heart of healthy people
Research type
Research Study
Full title
Interventional, Randomised, Partially Double-blind, Crossover, Positive controlled, Single dose Trial Investigating the Effect of LEO 152020 on Cardiac Repolarisation in Healthy Men and Women
IRAS ID
1005774
Contact name
Katya Uzunova
Contact email
Sponsor organisation
LEO Pharma A/S
Clinicaltrials.gov Identifier
Research summary
The planned study is being organised by LEO Pharma A/S as part of their development programme for this drug which is being developed as a potential treatment for itchy skin conditions known as Atopic dermatitis and Cholinergic urticaria. In a previous study involving this drug in healthy volunteers, there seemed to be a potential effect on the heart at high and repeated doses.
This study will be conducted at Labcorp Research in Leeds and will include healthy male and female participants aged between 18 and 55 years who meet the study entry criteria and who will also be required to be resident after successfully meeting the eligibility requirements for the study. Participants who successfully make it on to the study will be administered the study drug as a tablet alongside another different drug known to have an effect on the heart. This investigation will provide an opportunity to clearly recognise if indeed this drug being developed has the potential to affect the heart or not. In total there will be four treatment periods in which the study volunteers will take part in and will start at the first visit and they will stay in the unit until day two before discharge, after they have been administered treatment and the necessary assessments done in accordance with the protocol. Participants will repeat this process of admission to the unit and discharge until they have completed the four different admission and treatment periods separated each time by a minimum of 3 days between admission and treatment. At the completion of the four periods, participants will return to the study site for a safety follow-up visit which will be conducted 5 to 7 days post-final dose.
REC name
London - Hampstead Research Ethics Committee
REC reference
22/FT/0088
Date of REC Opinion
19 Aug 2022
REC opinion
Further Information Favourable Opinion