Status:
COMPLETED
Absorption, Metabolism, and Excretion of a Single Dose of Ferriprox® in Patients With Sickle Cell Disease
Lead Sponsor:
ApoPharma
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
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 Criteria
Inclusion
- Male or female, 18-45 years of age (inclusive)
- Diagnosis of sickle cell disease, confirmed by Hb electrophoresis
- Body weight ≥ 50 kg
- Body mass index (BMI) ≥ 18 and ≤ 32 kg/m\^2
- Absolute neutrophil count (ANC) of \>1.5 x 10\^9/L
- Women of childbearing potential must agree to either be sexually inactive or use an acceptable method of birth control for 14 days prior to dosing and for 30 days afterwards
- A fertile heterosexual male must agree that he or his partner will use an effective method of contraception for 14 days prior to dosing and for 30 days afterwards
Exclusion
- History or presence of hypersensitivity or idiosyncratic reaction to Ferriprox
- Use of Ferriprox within the past 3 months
- History of malignancy
- Evidence of abnormal liver function (serum Alanine Transaminase (ALT)level \> 5 times upper limit of normal or creatinine levels \>2 times upper limit of normal)
- A serious, unstable illness, as judged by the Investigator, within the past 3 months before screening visit including but not limited to hepatic, renal, gastro-enterologic, respiratory, cardiovascular, endocrinologic, neurologic or immunologic disease
- Hemodialysis during the week prior to dosing or planned for the day of dosing
- Known difficulty in providing blood samples
- Disorders or surgery of the gastrointestinal tract that may interfere with drug absorption or may otherwise influence the Pharmacokinetic (PK) results (e.g., resection of the small or large intestine, febrile conditions, chronic diarrhea, chronic vomiting, endocrine disease, severe infections, acute inflammations, etc.)
- Clinically significant abnormalities on 12-lead ECG (e.g., QT interval corrected using Fridericia's formula (QTcF) ≥ 430 ms in males or ≥ 450 ms in females)
- Use of tobacco/nicotine-containing products for at least 3 months prior to study drug administration
- Use of any drugs within the past 14 days that are metabolized by the Uridine diphosphate glucosyltransferase enzyme (UGT1A6) and hence could affect the PK of Ferriprox
- Treatment with an investigational drug within the past 30 days or 5 half-lives of that drug (whichever is longer) prior to study drug administration
- Pregnant or nursing female
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01835496
Start Date
May 1 2013
End Date
April 1 2014
Last Update
July 24 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHUM-Hôpital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1