NCT01552928

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

A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, 4-Period Crossover Trial to Assess the Effect of Anagrelide Hydrochloride on QT/QTc Interval in Healthy Men and Women.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Anagrelide 0.5 mg	0.5mg Anagrelide single oral dose
DRUG	Anagrelide 2.5 mg	2.5mg Anagrelide single oral dose
DRUG	Moxifloxacin	400 mg Moxifloxacin single oral dose
DRUG	Placebo	Anagrelide placebo + Moxifloxacin placebo single oral dose

Timeline

• Start date: 2012-03-29
• Primary completion: 2012-07-25
• Completion: 2012-07-25
• First posted: 2012-03-13
• Last updated: 2021-06-09
• Results posted: 2014-01-10

Locations

1 site across 1 country: France