At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 64 enrolled
Drug / intervention
Deferiprone +1 moredrug
Likely dose
Deferiprone 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Center, Phase I, Double-blind, Placebo-controlled Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Deferiprone Administered by Intravenous Infusion to Healthy Male and Female Volunteers
In Brief
A Phase 1 clinical trial evaluating Deferiprone and Placebo for Healthy Volunteers. Completed, enrolled 64 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedNov 2013
Primary CompletionMar 2014
TodayJul 2026
First PostedNov 21, 2013
Enrollment StartNov 1, 2013
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.6 years ago
Interventions
Deferipronedrug
Deferiprone for infusion, 10mg/mL for intravenous infusion. Oral dose of deferiprone: 80mg/mL oral solution. (Cohort 2)
Placebodrug
Placebo: normal saline solution.