Phase-I Study Evaluating the Pharmacokinetic Profile of RhuDex®
The drug that is under investigation during this study is RhuDex® and is expected to be used as an oral treatment for rheumatoid arthritis. Normal stomach juices contain acid and previous studies have shown that this acidity reduces the solubility and therefore the absorption of RhuDex®. Administering the alkaline buffer meglumine with RhuDex® has shown to increase the solubility of RhuDex® by decreasing the stomach acidity.
The purposes of this study are to determine:
- the optimum level of meglumine which is required to achieve the best uptake of RhuDex® from the stomach into the blood
- to determine the concentration of RhuDex® in the blood in the presence of the optimum level of meglumine
- to investigate further the safety and tolerability of RhuDex®. The study will be conducted in healthy male volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||An Open-Label, Partially Randomized, Cross-Over, Monocentric Phase I Study Evaluating the Pharmacokinetic Profile of RhuDex® in Order to Determine Optimum Doses of Meglumine and RhuDex®|
- Pharmacokinetic Profile
- Safety Profile
|Study Start Date:||September 2007|
|Study Completion Date:||November 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
RhuDex® is a novel, orally bioavailable, low molecular weight modulator of co-stimulation of T lymphocytes. RhuDex® binds to the protein CD80 on the surface of antigen-presenting cells and inhibits its interaction with CD28 (but not with CTLA-4) presented by CD4+ T lymphocytes.