Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers
Condition: Healthy
Intervention: Deferiprone extended release; Deferiprone immediate release
Intervention description: Deferiprone 1000 mg extended release tablet formulation; Ferriprox (deferiprone) 500 mg immediate release tablet formulation
Intervention MeSH terms: Deferiprone
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: deferiprone; deferiprone extended release formulation; pharmacokinetics

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.
    

Eligibility 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