How Does Voclosporin Work?
QTc Study Summary
| Trial Design: |
The study was a double-blind, parallel
group, placebo and moxifloxacin controlled, randomized, safety,
tolerance, pharmacokinetic, pharmacodynamic and QTc study of
trans-voclosporin in healthy subjects. |
|
Dosing Groups: |
Dose group 1- 0.5 mg/kg |
| Conclusion: | At therapeutic doses of trans-voclosporin (0.5 mg/kg), there were no ECG changes or QTc signals as compared to placebo. At a dose approximately 11 times higher than the anticipated therapeutic dose for the Phase III psoriasis trial there were no changes in cardiac conduction or morphology. The time averaged QTc change observed was 13 msec at the 4.5 mg/kg dose. |
Last updated March 27, 2008