Conditions: Healthy Volunteers
Keywords: Healthy Deferiprone DFP L1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 64
Healthy volunteers: yes

Brief summary:
Single center, randomized, double-blind, placebo-controlled, adaptive sequential ascending-dose study for the evaluation of the safety, tolerability, and pharmacokinetics of single doses of deferiprone administered by intravenous infusion to healthy males and females. A bioavailability comparison will be included.

Detailed description:

Arms:
arm 1: Single dose of 500mg deferiprone or placebo administered via intravenous infusion.

First 2 subjects to enroll: 1 will be randomized to receive deferiprone and the other to receive placebo.

Next 14 subjects enrolled: 13 will be randomized to receive deferiprone and 1 to receive placebo. arm 2: Single dose of 1000mg deferiprone or placebo administered via intravenous infusion and oral solution.

Randomization will be done for all 16 subjects at the same time: 14 will be randomized to receive deferiprone and 2 to receive placebo.

Subjects enrolled to cohort 2 will receive an oral dose of deferiprone. arm 3: Single dose of 1500mg deferiprone or placebo administered via intravenous infusion.

Randomization will be done for all 16 subjects at the same time, 14 will be randomized to receive deferiprone and 2 to receive placebo. arm 4: Single dose of 2000mg deferiprone or placebo administered via intravenous infusion.

First 2 subjects to enroll: 1 will be randomized to receive deferiprone and the other to receive placebo.

Next 14 subjects enrolled: 13 will be randomized to receive deferiprone and 1 to receive placebo.

Interventions: intervention 1: Deferiprone intervention 2: Placebo
Intervention descriptions: intervention 1: Deferiprone for infusion, 10mg/mL for intravenous infusion.

Oral dose of deferiprone: 80mg/mL oral solution. (Cohort 2) intervention 2: Placebo: normal saline solution.

Protocol document: