Study 105 is a Phase I three-way crossover study of a single-dose of ADX10059, to study potential interactions with proton-pump inhibitors and food. The primary objectives are pharmacokinetics, tolerability and safety. The study in 15 healthy volunteers is scheduled to report data in September 2008.
The objective for the new formulations is to reduce the rapid absorption and onset of action of ADX10059 while optimizing the exposure profile compared to the original form, the active pharmaceutical ingredient (API) in capsules, which was used in Phase IIa testing. In preclinical studies new formulations of ADX10059 reduced the rapid absorption and improved the exposure profile compared to API filled capsules.
A formulation of ADX10059 was selected at the end of May, 2008 upon completion of part one of Study 104, a separate ongoing Phase I trial. Phase IIb trials of ADX10059 are scheduled to start in the fourth quarter of 2008 in gastroesophageal reflux disease (GERD) and migraine prevention.
Charlotte Keywood, chief medical officer of Addex, said: “We have selected the best new formulation for further study. In addition to studying the interactions of ADX10059 with proton pump inhibitors and food in Study 105, our goal in part two of Study 104 is to show that we are able to achieve the optimized exposure profile in humans.”