Bioavailability and Food Effect Study in Healthy Volunteers
Research type
Research Study
Full title
LP0058-1005 - A Phase I, Open-Label, Four-Way Crossover and Food-Effect Study of LEO 32731 in Healthy Subjects when Administered as an Immediate and Modified Release Formulation
IRAS ID
143712
Contact name
Ashley Brooks
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2013-004346-41
ISRCTN Number
n/a
Research summary
The Study Drug is a drug currently developed as oral treatment for atopic dermatitis (AD) and psoriasis. In atopic dermatitis or eczema, the skin becomes extremely itchy and inflamed causing redness, swelling, cracking, weeping, crusting, and scaling. The disease tends to run in families and affects 2-10% of the adult population and 15–30% of children worldwide.
Psoriasis is a multisystem disease with predominantly skin and joint problems, affecting approximately 1 to 3% of the population. It is characterised by scaly plaques which are often itchy. Psoriasis is a disabling disease which may have a significant impact on patients’ overall health-related quality of life.
The study drug is a selective phosphodiesterase 4 (PDE4). PDE4 inhibitors are a well characterised class of pharmaceutical agents with a broad range of anti-inflammatory activities. The study drug works by controlling the release of chemicals that play a role in the development of AD and psoriasis, and thus it is hoped that the study drug will be helpful for these patients with few undesirable side effects.
The study drug has been tested in previous clinical trials in different formulations. This study will use a new formulation (modified release) with the aim of improving tolerance and fewer side effects in comparison to the previously tested (immediate release) formulation.
The study will be in 2 parts; Part 1 will assess relative bioavailability (absorption properties) of 4 different formulations and Part 2 will assess the effect of food on absorption of the study drug.
Subject participation is expected to last up to 9 weeks in Part 1 and 7 weeks in Part 2, from the time of screening till the last post-study visit.
REC name
North East - York Research Ethics Committee
REC reference
14/NE/0046
Date of REC Opinion
25 Apr 2014
REC opinion
Further Information Favourable Opinion