Thorough QT/QTc (Corrected QT Interval) Study to Evaluate the Effect of Custirsen on Cardiac Repolarization
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
This is a 3-arm, parallel-group, active- and placebo-controlled, double-blind, randomized
study, to compare treatment with intravenous custirsen at 640 mg (highest intended
therapeutic dose) with placebo. The purpose of this study is to assess the effect of
custirsen treatment on cardiac conduction and repolarization (electrical activity of the
heart) in healthy subjects. The positive control employed to demonstrate assay sensitivity
consists of a group receiving a single oral dose of 400 mg moxifloxacin on day 7. The
moxifloxacin arm is un-blinded but the ECG readings are blinded.
Phase:
Phase 1
Details
Lead Sponsor:
Achieve Life Sciences OncoGenex Technologies
Collaborators:
Teva Branded Pharmaceutical Products R&D, Inc. Teva Pharmaceutical Industries
Treatments:
Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination