Comparison of 5 formulations & food effect in healthy males
Research type
Research Study
Full title
Comparison of 5 different formulations and food effect assessment on pharmacokinetics of S42909 after a single oral administration in young healthy male participants. A monocentre, open labelled, randomized, five way crossover pharmacokinetic study
IRAS ID
122986
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Servier Research and Development Limited
Eudract number
2012-001105-25
ISRCTN Number
n/a
Research summary
S 42909 (study drug) is being developed for the treatment of leg ulcers caused primarily by venous disease. In normal circulation, arteries carry oxygen-rich blood from the heart to the body, and veins return the blood back to the heart. If the veins become weak or damaged the blood flow back to the heart slows down and blood Pressure inside the veins increases - creating a disorder known as venous disease. When venous disease becomes severe, ulcers can occur in the skin particularly in the leg around the ankles. Venous disease is quite common - about 15% of the adult population is affected and about 1% will have venous ulcer at some point in their lives. It is hoped that this drug will stop or slow down a number of processes that occur in the body and lead to leg ulcer formation. The study drug has been tested in 4 Clinical Studies so far. S42909 was considered to be generally safe and well tolerated in these studies. The sponsor has developed 4 new different formulations (different manufacturing methods) of the study drug in order to compare the absorption properties of each following administration. In this study, subjects will receive a single 600 mg oral dose of each of the new formulations (Formulations A, B, C, and D) in each treatment period and this will be compared to the same dose of the reference formulation (Formulation R). The effect of food on drug levels of S 42909 and its breakdown products will also be assessed after administration of one of the four new formulations. The 4 new formulations developed for oral administration of S 42909 will offer the opportunity to reach equivalent or higher blood levels of S 42909 compared to the former formulation used in previous studies. This is a single site study involving up to 15 healthy adult male subjects who will be participating in 6 treatments periods ( administration of 4 new formulations, administration of the reference formulation, and food effect assessment).Subject participation is expected to last up to 10 weeks from the time of screening till the last post-study visit.
REC name
North East - York Research Ethics Committee
REC reference
13/NE/0076
Date of REC Opinion
14 Mar 2013
REC opinion
Favourable Opinion