PK study of LAS41008 120mg and Fumaderm 120mg in healthy subjects
Research type
Research Study
Full title
A Randomized, Open-label, Single-center, Four-way Crossover, Single Dose Study to Investigate the Pharmacokinetics of LAS41008 120 mg Gastro-resistant Tablet and Fumaderm® 120 mg Gastro-resistant Tablet Under Fasting and Fed Conditions in Healthy Subjects.
IRAS ID
209296
Contact name
Pablo Forte Soto
Contact email
Sponsor organisation
Almirall, S.A.
Eudract number
2016-002314-50
Duration of Study in the UK
0 years, 1 months, 19 days
Research summary
This is a randomised, open-label, single-centre, four-way crossover clinical trial to investigate the pharmacokinetics of a single dose of the sponsor’s study drug (test product), LAS41008 120 mg Gastro-resistant Tablet, and the reference product, Fumaderm® 120 mg Gastro resistant Tablet, under fasted and fed conditions in healthy male and female subjects. The study will comprise a screening visit, four different treatment periods and a telephone interview a few days after the last dose of study medication was administered. The study is divided into four treatment sequences. Subjects will be randomised to participate in one treatment sequence only.
This is not a first-time-in-human study. This means that the test product studied in this research programme has been given to humans before. The test product is being developed by the sponsor as treatment for moderate to severe plaque psoriasis in adults. Psoriasis is a chronic inflammatory condition primarily affecting the skin. Disease changes to the skin include an abnormally high rate of cell production, white blood cell infiltrations and changes in the lining of blood vessels in the skin. The study drug works by indirectly causing lowering of the inflammatory response and its consequences. The study medication will be taken orally in the form of tablets to be taken with water.
The main purpose of the study is to investigate how the study medication is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body). The study will also see how safe the drug is after single doses were taken.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
16/EE/0230
Date of REC Opinion
7 Sep 2016
REC opinion
Further Information Favourable Opinion