drugset / Trial / NCT01552928

Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers

NCT01552928

Phase 1 Completed 60 enrolled Shire
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2012-03-29
Primary completion
2012-07-25
Completion
2012-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Anagrelide Small molecule 0.5 mg Oral
Subject Anagrelide Small molecule 2.5 mg Oral
Comparator Moxifloxacin Small molecule 400 mg Oral

Indications

No indication recorded.