Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers
Information source: ApoPharma
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Deferiprone extended release (Drug); Deferiprone immediate release (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: ApoPharma Official(s) and/or principal investigator(s): Eric Sicard, MD, Principal Investigator, Affiliation: Algorithme Pharma Inc
Summary
The purpose of this study is to look at the pharmacokinetics of a new formulation of
deferiprone (deferiprone extended release tablets) under fed and fasting conditions.
Clinical Details
Official title: Single-dose Pharmacokinetic Study of Deferiprone Extended Release Tablets Versus Ferriprox Immediate Release Tablets Under Fasting and Fed Conditions in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Cmax for serum deferiprone and deferiprone 3-O-glucuronideTmax for serum deferiprone and deferiprone 3-O-glucuronide AUC0-∞for serum deferiprone and deferiprone 3-O-glucuronide
Secondary outcome: Number of subjects with adverse events (AEs)
Detailed description:
This is a single-center, open-label, randomized, 5-period, 5-sequence study of the
pharmacokinetics of a new formulation of deferiprone, extended release tablets, in twenty
healthy volunteers. In each study period, blood samples for pharmacokinetics assessment will
be collected pre-dose and over 24 hours post-dose. Safety will be assessed throughout the
study.
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female aged ≥18 to <50 years
2. A female volunteer of childbearing potential must agree to use an accepted
contraceptive regimen from at least 28 days prior to the first administration of the
study drug until at least 30 days after the last dose of the study drug
3. A sexually active male must agree that he and/or his female partner will use a
medically acceptable method of contraception throughout the study and for at least 30
days following drug administration
4. Body mass index (BMI) greater than or equal to 18. 5 kg/m^2 and below 30. 0 kg/m^2
5. Body weight of at least 60 kg
6. Non- or ex smoker
7. Clinical laboratory values within the laboratory's stated normal range; if not within
this range, an abnormal value must be without any clinical significance
8. Have no clinically significant diseases captured in the medical history, or evidence
of clinically significant findings on physical examination and/or clinical laboratory
evaluations (hematology, general biochemistry, coagulation, ECG, and urinalysis)
Exclusion Criteria:
1. Pregnant or breastfeeding
2. Absolute neutrophil count (ANC) < 1. 8 x 109/L at screening (no repeat can be
performed)
3. History of significant hypersensitivity to deferiprone or any related products
(including excipients of the formulations) as well as severe hypersensitivity
reactions (such as angioedema) to any drugs
4. History or presence of gastrointestinal, liver or kidney disease, or any other
conditions known to interfere with the absorption, distribution, metabolism, or
excretion of drugs or known to potentiate or predispose to undesired effects
5. Presence of significant cardiovascular, pulmonary, hematologic, neurological,
psychiatric, endocrine, immunologic or dermatologic disease
6. Suicidal tendency, history of seizures, history of head trauma with coma or
craniotomy/trepanation, state of confusion, or clinically relevant psychiatric
diseases
7. Presence of out-of-range cardiac interval (PR < 110 msec, PR > 220 msec, QRS < 60
msec, QRS >119 msec and QTcF > 450 msec for males and > 460 msec for females) on the
screening ECG or other clinically significant ECG abnormalities
8. Maintenance therapy with any drug or significant history of drug dependency or
alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or
chronic)
9. Any clinically significant illness in the previous 28 days before Day 1 of this study
10. Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450
(CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin,
ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong
inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids,
phenytoin, rifampin and St John's Wort), in the previous 28 days before Day 1 of this
study
11. Any history of tuberculosis and/or prophylaxis for tuberculosis
12. Serum ferritin value below the normal limit of the reference laboratory at screening
13. Positive urine screening of alcohol and/or drugs of abuse
14. Positive results on HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B)
(hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests
15. Positive result on a serum pregnancy test
16. Receipt of an investigational product in another clinical trial in the previous 28
days before Day 1 of this study
17. Donation of 50 mL or more of blood in the previous 28 days before Day 1 of this study
or donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec,
clinical studies, etc.) in the previous 56 days before Day 1 of this study
Locations and Contacts
Algorithme Pharma Inc., Mount-Royal, Quebec H3P 3P1, Canada
Additional Information
Starting date: June 2015
Last updated: July 9, 2015
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