NCT01835496

Absorption, Metabolism, and Excretion of a Single Dose of Ferriprox® in Patients With Sickle Cell Disease

The Pharmacokinetic Profile of a Single Dose of Ferriprox® in Patients With Sickle Cell Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: ApoPharma · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the pharmacokinetics of deferiprone and its 3-O-glucuronide metabolite following administration of a single 1500 mg dose of Ferriprox in patients with sickle cell disease.

Detailed description

This is a single-arm, single-dose study of Ferriprox in patients with sickle cell disease. Patients found to be eligible will visit the clinic the day before receiving the drug, in order to reconfirm eligibility and to undergo baseline assessments, and will receive a single dose of 1500 mg Ferriprox under fasting conditions. Blood and urine samples for pharmacokinetic assessment will be collected over a 10-hour period. Standard safety assessments will be performed throughout the study, and patients will return for a safety follow-up.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	single 1500 mg dose of Ferriprox	A single dose of 1500mg of Ferriprox (three 500mg tablets) administered under fasting conditions

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-04-19
• Last updated: 2015-07-24
• Results posted: 2015-07-24

Locations

1 site across 1 country: Canada