A Study to Evaluate the Effect of Gabapentin on Cardiac Repolarization in Healthy Volunteers
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
This will be a randomized, double-blind, placebo- controlled cross-over study to investigate
the effect of GEn on cardiac repolarisation parameters compared with placebo and a positive
control, moxifloxacin. Approximately 52 subjects will be recruited to the study and will take
part in four dosing sessions. Subjects will receive, in a randomized order, a single dose of
1200 mg GEn, 6000 mg GEn (supratherapeutic dose), 400 mg moxifloxacin (positive control) and
placebo. Twelve lead continuous ECG monitoring will be conducted from pre-dose to
approximately 24 hours after dosing on Day 1 of each study session. The primary comparison of
interest will be the mean change from baseline in the time-matched differences in QTcF
between each GEn treatment and placebo.
Phase:
Phase 1
Details
Lead Sponsor:
XenoPort, Inc.
Treatments:
Fluoroquinolones Gabapentin Moxifloxacin Norgestimate, ethinyl estradiol drug combination