A double-blinded, placebo-controlled, randomized, crossover study of 8 healthy human volunteers was conducted. Subjects ingested 5 mg/kg of elemental iron in the form of ferrous sulfate. One hour after iron ingestion, subjects were randomized to receive 20 mg/kg of deferasirox or placebo. Serial iron levels were then obtained. A 2-week washout was used between study arms. The paired t test was used to compare area under time-concentration curves from baseline to both 12- and 24-hour iron levels between groups.
Baseline serum iron levels were similar in the 2 groups. Deferasirox significantly reduced serum iron area under concentration-time curves compared with placebo during both 1 to 12 hours and 1 to 24 hours (12 hour=577 μmol-hour/L and 392 μmol-hour/L, 95 % confidence interval for the difference 15.8 to 353.0 μmol-hour/L; 24 hour=808 μmol-hour/L and 598 μmol-hour/L, 95 % confidence interval for difference 54.4 to 366.7 μmol-hour/L).
Orally administered deferasirox significantly reduced serum iron levels when administered 1 hour after iron ingestion during the 12- and 24-hour periods after acute ingestion of 5 mg/kg of elemental iron in healthy human volunteers. Further study is required to determine optimal dosing, but deferasirox may be an important addition to current therapy for acute iron poisoning.