LEO 32731 - DDI Study with LEO 32731 and Midazolam in healthy males
Research type
Research Study
Full title
LEO 32731 - A Phase I Drug-Drug Interaction Study with LEO 32731 and Midazolam in Healthy Male Subjects
IRAS ID
201389
Contact name
Ashley Brooks
Contact email
Sponsor organisation
LEO Pharma A/S
Eudract number
2015-005073-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 14 days
Research summary
LEO 32731 is a drug being developed for the topical treatment of atopic dermatitis (AD) and the oral treatment of psoriasis. \nAtopic dermatitis or, atopic eczema, is a chronically relapsing, pruritic inflammatory skin disease. 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% to 10% of the adult population and 15% to 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.\nThe study drug (LEO 32731) is a selective phosphodiesterase 4 (PDE4) inhibitor. PDE4 inhibitors are a well characterised class of pharmaceutical agents with a broad range of anti-inflammatory activities. LEO 32731 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. \nThe study drug (LEO 32731) has been tested in previous clinical trials in different formulations. This study will be a drug interaction study to see if LEO 32731 has an effect on the amount of another drug (midazolam) in the bloodstream when they are taken at the same time.\nSubject participation is expected to last up to 54 days from the time of screening till the last post-study visit. \n\n
REC name
London - Bloomsbury Research Ethics Committee
REC reference
16/LO/0330
Date of REC Opinion
11 Apr 2016
REC opinion
Further Information Favourable Opinion