A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase I Study of Analgesic/Antihyperalgesic Properties of ASP8477, a Fatty Acid Amide Hydrolase Inhibitor, in Healthy Female Subjects.

ABSTRACT: Objectives:To evaluate the analgesic/antihyperalgesic effect of ASP8477. Design:Randomized, double-blind, double-dummy, cross-over, placebo- and active comparator-controlled study. Setting:HPR Dr. Schaffler GmbH, Munich, Germany. Subjects:Healthy female subjects aged 18-65 years. Methods:Eligible subjects were randomly assigned to one of six treatment sequences and received multiple ascending doses of ASP8477, duloxetine, and placebo over three treatment periods (each consisting of 21-day dosing separated by 14-day washout periods). On the last day of each dose level, laser evoked potentials (LEPs) and visual analog scales (VAS pain) on capsaicin-treated skin at baseline and at multiple postdose time points were assessed. The primary end point was the difference in LEP N2-P2 peak-to-peak (

SUBMITTER: Schaffler K 

PROVIDER: S-EPMC5998989 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature