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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
8
A single dose of 1500mg of Ferriprox (three 500mg tablets) administered under fasting conditions
CHUM-Hôpital Notre-Dame
Montreal, Quebec, Canada
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Cmax (maximum measured serum concentration) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.
Time frame: 10-hour interval
Tmax for Deferiprone and Deferiprone 3-O-glucuronide
Tmax (time to the maximum measured serum concentration) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose. The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation).
Time frame: 10-hour interval
AUC0-∞ for Serum Deferiprone and Deferiprone 3-O-glucuronide
AUC0-∞ (area under the curve, zero to infinity) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.
Time frame: 10-hour interval
T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide
T1/2 (apparent terminal elimination half-life) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.
Time frame: 10-hour interval
Frequency of Adverse Events
Time frame: From Day 1 (Dosing) to Day 7 plus/minus 3 days (Follow-up)
Frequency of Serious Adverse Events
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Time frame: From Day 1 (Dosing) to Day 30 post-dose