Conditions: Prolonged QTc Interval
Keywords: Ferriprox® LI DFP Deferiprone Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 50
Healthy volunteers: yes

Brief 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®).

Arms:
arm 1: Single dose of 33 mg/kg rounded to the nearest 250 mg of deferiprone tablets arm 2: Single dose of 50 mg/kg rounded to the nearest 250 mg of deferiprone tablets arm 3: Single dose of matching deferiprone and moxifloxacin placebo tablets. arm 4: Single dose of one 400 mg moxifloxacin tablet.

Interventions: intervention 1: Deferiprone intervention 2: deferiprone matching placebo tablets intervention 3: moxifloxacin intervention 4: placebo
Intervention descriptions: intervention 1: Ferriprox 500 mg tablets intervention 2: deferiprone matching placebo tablets intervention 3: Active control intervention 4: moxifloxacin-matching placebo

Protocol document: