Effect of GSK1014802 on Electrical Hyperalgesia and Threshold Tracking in Healthy Subjects
Status:
Terminated
Trial end date:
2009-11-30
Target enrollment:
Participant gender:
Summary
This study is being conducted to assess the effects of GSK1014802 and a positive control,
lidocaine, on tests of peripheral nerve excitability. This will be a double blind, placebo
controlled, 4-period cross over study. Approximately 20 subjects will be randomised to one of
two doses of a GSK1014802, lidocaine and placebo with at least 2 weeks between sessions. A
follow-up will occur 7-15 days after the last dose.
During treatment session 3 on the 6th October 2009, one subject had a pattern of AEs of
severe intensity, suggestive of brain stem toxicity / encephalopathy during the
lidocaine/saline infusion period. Although recognised in the literature when lidocaine was
used in patients for treatment of pain, these AEs were unusual in studies in healthy
subjects. The study was suspended to allow re-evaluation of the risk:benefit balance of
lidocaine/saline infusion in healthy subjects in this study. It was decided that continuation
of the use of lidocaine (positive control) would risk the safety of subjects. Continuation
without the positive control was not possible as it would compromise the scientific integrity
of the design.