Conditions: Sickle Cell Disease
Keywords: sickle cell disease iron overload pharmacokinetics Ferriprox deferiprone
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

Brief 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.

Arms:
arm 1: single 1500 mg dose of Ferriprox

Interventions: intervention 1: single 1500 mg dose of Ferriprox
Intervention descriptions: intervention 1: A single dose of 1500mg of Ferriprox (three 500mg tablets) administered under fasting conditions

Protocol document: