Open-label trial to evaluate the FE of LEO 152020 film-coated tablets
Research type
Research Study
Full title
A Phase 1, open-label, randomised, cross-over trial to evaluate the food effect of LEO 152020 film-coated tablets in healthy adult subjects
IRAS ID
287683
Contact name
Hamzah Malik
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2020-003924-18
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
20/NE/0197, REC ref
Duration of Study in the UK
0 years, 1 months, 29 days
Research summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease (often referred to as eczema) characterised by widespread skin lesions, manifested as red, itchy, swollen, cracked, weeping lesions with crusting/scaling, intractable pruritus (itch), and enhanced susceptibility to bacterial and viral skin infections. Persistent itch that often causes sleep deprivation and disfiguration of the skin substantially impairs a patient’s quality of life.
LEO 152020 is a new oral treatment for the treatment of atopic dermatitis, which is classed as a histamine (a chemical released by cells in our body in response to injury and in an allergic and inflammatory reactions) 4 receptor antagonist (H4R). LEO 152020 is expected to have antipruritic (reduce itching) and anti-inflammatory effects for moderate to severe atopic dermatitis.
This trial investigates the influence of food intake on absorption of LEO 152020 and if no food effect is observed subsequent trials would not require restrictions on food intake.
Subjects will receive 2 single oral doses of LEO 152020 one in the fed state and one in the fasted state. There will be a minimum of 4 days between dosing of the subjects in each of the fed or fasted state.
A total of 12 subjects will be enrolled onto the study, there will be two treatment periods and the subjects will be confined to the unit for 4 days for each treatment period.
Each treatment period includes:
• A screening visit from 2 days to 30 days before the first dose of IMP.
• An in-clinic treatment followed by a 48-hour follow-up period; this follow-up period includes PK (how the drug moves around the body) sampling over 48 hours after the last dose.
• An in-clinic, safety follow-up visits 2 days after last dosing in the second treatment period.REC name
North East - York Research Ethics Committee
REC reference
20/NE/0197
Date of REC Opinion
6 Oct 2020
REC opinion
Favourable Opinion