Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.XenoPort has announced dosing of first patient in the Phase I trial evaluating the pharmacokinetics, safety and tolerability of a single dose of XP23829 administered in both fasted and fed conditions.
Subscribe to our email newsletter
XP23829 is a novel fumarate analog for the potential treatment of relapsing-remitting multiple sclerosis and psoriasis, which demonstrated a greater degree of efficacy compared to Dimethyl fumarate in preclinical animal models of both multiple sclerosis and psoriasis.
The randomized, double-blind study is designed to assign approximately 60 health individuals to one of five cohorts with each cohort receiving one of four different formulations of XP23829 or placebo.
XenoPort chief executive officer Ronald Barrett said dosing of the first human subject with XP23829 is an important milestone to develop the potential best-in-class fumarate analog.
"One goal of this study is to verify that XP23829 is efficiently metabolized to produce MMF in the blood," Barrett added.
"We believe that the MMF pharmacokinetic profiles produced by the different XP23829 formulations administered with and without food will be instructive for the selection of one or more formulations to take forward into future trials."
In the two-period crossover food effect comparison study, subjects will be given in a single dose of XP23829 or placebo in both a fasted and fed state in randomised order and then the blood levels of XP23829, its active metabolite, monomethyl fumarate, and other potential metabolites will be assessed.