Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization
| Status: | Archived |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | March 2012 |
| End Date: | June 2012 |
| Contact: | Astellas Pharma Global Development |
| Email: | clintrials.info@us.astellas.com |
| Phone: | 800-888-7704 |
A Phase 1, Randomized, Double Blind, Placebo and Active Controlled, Parallel Study to Evaluate the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization in Healthy Adult Subjects
This study is designed to evaluate repeat doses of isavuconazole on cardiac repolarization
in healthy adult subjects. Eligible subjects will be randomized to one of four treatment
groups and be confined for 17 days including pre-dosing days. Moxifloxacin will be given as
an active control on the last dosing day to healthy subjects in one of the four groups. All
treatments, except the moxifloxacin dose, are double-blinded (neither the subject nor the
study doctor will know the treatment assignment). Subjects will undergo continuous ECGs on
three study days. ECGs, vital signs, blood draws will be obtained throughout the study for
safety and to assess the amount of study drug in body.
We found this trial at
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