Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers
Status:
Completed
Trial end date:
2012-07-25
Target enrollment:
Participant gender:
Summary
According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated
for their ability to prolong the QT interval which represents the duration of ventricular
depolarization and subsequent repolarization. The primary objective of the study is to assess
the effect of anagrelide on QT/QTc interval following a therapeutic and supratherapeutic dose
of anagrelide when compared to placebo and a positive control.
Phase:
Phase 1
Details
Lead Sponsor:
Shire
Treatments:
Anagrelide Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination