Study of the Effect of Repeat Doses of Isavuconazole on Cardiac Repolarization
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Collaborator:
Basilea Pharmaceutica International Ltd
Treatments:
Isavuconazole Moxifloxacin Norgestimate, ethinyl estradiol drug combination