A trial to assess PK of Single Oral Doses of 2 Different Formulations of LEO152020 in Healthy people
Research type
Research Study
Full title
A Phase 1, Open-Label, Randomized, Two-Period Trial to Investigate the Pharmacokinetics of Single Oral Doses of Two Different Formulations of LEO 152020 in Healthy Subjects
IRAS ID
1006241
Contact name
Jakob Mueller
Contact email
Sponsor organisation
LEO Pharma A/S
Research summary
The Study Drug is an investigational drug being developed by the sponsor as a potential treatment for eczema and for patients with recurring skin hives.
The current treatments for eczema and recurring hives have side effects or might not be very effective, and it is hoped that the Study Drug will be more effective with fewer side effects.
To date, the Study Drug has been tested extensively in animals at doses higher than the dose planned for this trial. It has also been tested in two trials in healthy human participants. The Study Drug has been well-tolerated so far with few side effects at the dose levels proposed for this trial.
The purpose of this trial is to compare the pharmacokinetic data (blood drug levels) from 2 formulations of the Study Drug in healthy subjects. The original tablet (Tablet B) which has been tested in previous trials will be compared to the new tablet (Tablet G). The new formulation (Tablet G) has not been used before and is planned for use in future clinical trials.
This study is being performed as part of the development program for the Study Drug.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0178
Date of REC Opinion
7 Nov 2022
REC opinion
Further Information Favourable Opinion