NCT01860703

Evaluation of Whether Deferiprone Affects QT Interval in Healthy Subjects

A Double-Blind, Randomized, Crossover, Thorough QT/QTc Trial to Evaluate the Potential of Deferiprone to Prolong the QT Interval in Healthy Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: ApoPharma · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Randomized, single-dose, double-blind, placebo and active controlled, four-period crossover study to evaluate the effect of deferiprone on QTc prolongation after administration of a single therapeutic (33 mg/kg) and supratherapeutic(50 mg/kg) oral doses of deferiprone in healthy volunteers as compared to placebo treatment.

Detailed description

Post-marketing study to evaluate the effect of deferiprone and deferiprone 3-O-glucuronide on QTc prolongation in healthy volunteers after administration of a single therapeutic (33 mg/kg) and supratherapeutic (50 mg/kg) oral dose of deferiprone and moxifloxacin (Avelox®).

Conditions

• Prolonged QTc Interval

Interventions

Type	Name	Description
DRUG	Deferiprone	Ferriprox 500 mg tablets
DRUG	deferiprone matching placebo tablets	deferiprone matching placebo tablets
DRUG	moxifloxacin	Active control
DRUG	placebo	moxifloxacin-matching placebo

Timeline

• Start date: 2012-11-01
• Primary completion: 2012-12-01
• Completion: 2013-07-01
• First posted: 2013-05-23
• Last updated: 2014-11-12
• Results posted: 2014-11-12

Locations

1 site across 1 country: United States