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
Schaffler K, Yassen A, Reeh P, Passier P (2018)
Publication Type: Journal article
Publication year: 2018
Journal
Book Volume: 19
Pages Range: 1206-1218
Journal Issue: 6
DOI: 10.1093/pm/pnx281
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 (PtP) amplitudes for ASP8477 100 mg vs placebo. Results: Twenty-five subjects were randomized. In all subjects, LEP N2-P2 PtP amplitudes were numerically lower for ASP8477 100 mg vs placebo (P = 0.0721); in subjects who demonstrated positive capsaicin skin effects, a greater mean difference of -2.24 µV (P = 0.0146) was observed. Across all doses, LEP N2-P2 PtP amplitudes were lower for duloxetine compared with ASP8477 (mean difference -3.80 µV; P < 0.0001) or placebo (mean difference -5.21 µV; P < 0.0001). The effect of ASP8477 (all doses) on down-scoring the VAS pain score was significant compared with placebo (mean difference -2.55%; P < 0.0007). Conclusions: ASP8477 was well tolerated in this study. Analysis of all subjects did not demonstrate a significant difference in LEP for ASP8477 100 mg over placebo but did in subjects who demonstrated positive capsaicin skin effects.
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Germany (DE)How to cite
APA:
Schaffler, K., Yassen, A., Reeh, P., & Passier, P. (2018). 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. Pain Medicine, 19(6), 1206-1218. https://dx.doi.org/10.1093/pm/pnx281
MLA:
Schaffler, Klaus, et al. "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." Pain Medicine 19.6 (2018): 1206-1218.
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