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Evaluation of Whether Deferiprone Affects QT Interval in Healthy Subjects

NCT01860703 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-11-12

Study results available
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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.

Conditions

  • Prolonged QTc Interval

Interventions

DRUG

Deferiprone

Ferriprox 500 mg tablets

DRUG

deferiprone matching placebo tablets

deferiprone matching placebo tablets

DRUG

moxifloxacin

Active control

DRUG

placebo

moxifloxacin-matching placebo

Sponsors & Collaborators

  • ApoPharma

    lead INDUSTRY

Principal Investigators

  • Fernando Tricta, MD · ApoPharma

  • Caroline Fradette, PhD · ApoPharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2012-12-31
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01860703 on ClinicalTrials.gov