Drug Drug Interaction Study With Gabapentin Enacarbil and Morphine

Summary

This double-blind study will evaluate the pharmacokinetics of a single dose of morphine or gabapentin derived from gabapentin enacarbil (GEn) after administration of morphine and GEn alone and in combination as well as the tolerability of morphine administered with GEn. The dose of GEn will be 600 mg administered with food. Morphine/morphine placebo will be administered 2 hours prior to GEn/GEn placebo in the fasted state. A 60 mg dose of a controlled release formulation of morphine will be given. Blood samples for evaluation of gabapentin, morphine and morphine-6-glucuronide will be collected. The pharmacodynamic effect of co-administering both treatments will be assessed using visual analog scales for somnolence/sedation, dizziness and nausea.

Timeline

Start

2011-08

Primary completion

2011-10

Completion

2011-10

Publications

• Chen C, Upward J, Arumugham T, Stier B, Davy M. Gabapentin enacarbil and morphine administered in combination versus alone: a double-blind, randomized, pharmacokinetic, and tolerability comparison. Clin Ther. 2015 Feb 1;37(2):349-57. doi: 10.1016/j.clinthera.2014.10.015. Epub 2014 Nov 20.

Drugs

Indications