XenoPort, Inc. (Nasdaq: XNPT) announced today that the first subjects
have been dosed in a Phase 1, randomized, double-blind, two-period
crossover, food effect comparison study of XP23829 in healthy adults.
The trial is designed to assess the pharmacokinetics, safety and
tolerability of a single dose of XP23829 administered in both fasted and
Approximately 60 subjects will be assigned to one of five cohorts with
each cohort receiving one of four different formulations of XP23829 or
placebo. Subjects will receive a single dose of XP23829 or placebo in
both a fasted and fed state in randomized order. The trial will assess
the blood levels of XP23829, its active metabolite, monomethyl fumarate
(MMF), and other potential metabolites. The four XP23829 formulations
will include one immediate-release formulation and three
extended-release formulations that are designed for possible once-a-day
dosing of XP23829.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, said,
"Dosing of the first human subject with XP23829 is an important
milestone as we work to develop this 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. 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."