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Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02442310
Recruitment Status : Completed
First Posted : May 13, 2015
Results First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
Algorithme Pharma Inc
Information provided by (Responsible Party):
ApoPharma

Brief Summary:
The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Deferiprone delayed release tablet formulation Drug: Deferiprone oral solution Phase 1

Detailed Description:
This is a single-center, open-label, randomized, 4-period crossover study of the pharmacokinetics of a new formulation of deferiprone, delayed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Single Dose Crossover Comparative Bioavailability Study of Deferiprone 600 mg Delayed Release Tablets Versus Deferiprone Oral Solution in Healthy Male and Female Volunteers Following a 1200 mg Dose
Study Start Date : May 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Deferiprone

Arm Intervention/treatment
Experimental: Delayed release, fed conditions
A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast
Drug: Deferiprone delayed release tablet formulation
Deferiprone 600 mg delayed release tablet formulation
Other Name: Deferiprone

Experimental: Delayed release, fasting conditions
A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast
Drug: Deferiprone delayed release tablet formulation
Deferiprone 600 mg delayed release tablet formulation
Other Name: Deferiprone

Experimental: Delayed release half-tablets
A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast
Drug: Deferiprone delayed release tablet formulation
Deferiprone 600 mg delayed release tablet formulation
Other Name: Deferiprone

Active Comparator: Oral solution, fasting conditions
A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast
Drug: Deferiprone oral solution
Deferiprone 100 mg/mL oral solution
Other Name: Ferriprox




Primary Outcome Measures :
  1. Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide [ Time Frame: 24-hour interval ]
    Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose

  2. Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide [ Time Frame: 24-hour interval ]
    Time to maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose

  3. AUC0-∞for Serum Deferiprone and Deferiprone 3-O-glucuronide [ Time Frame: 24-hour interval ]
    Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose


Secondary Outcome Measures :
  1. Number of Subjects With Adverse Events (AEs) [ Time Frame: Throughout the trial, from the time of the first dose until the last study visit (Day 30 or early termination) ]
    Number of subjects with AEs, by frequency, severity, time to onset, duration, and relatedness to study product. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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. Non- or ex smoker
  6. Clinical laboratory values within the laboratory's stated normal range; if not within this range, an abnormal value must be without any clinical significance
  7. 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. 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
  7. 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)
  8. Any clinically significant illness in the previous 28 days before Day 1 of this study
  9. Serum ferritin value below the normal limit of the reference laboratory at screening
  10. Positive urine screening of alcohol and/or drugs of abuse
  11. Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442310


Locations
Canada, Quebec
Algorithme Pharma Inc.
Mount-Royal, Quebec, Canada, H3P 3P1
Sponsors and Collaborators
ApoPharma
Algorithme Pharma Inc
Investigators
Study Chair: Fernando Tricta, MD ApoPharma Inc.

Responsible Party: ApoPharma
ClinicalTrials.gov Identifier: NCT02442310     History of Changes
Other Study ID Numbers: LA46-0114
First Posted: May 13, 2015    Key Record Dates
Results First Posted: May 13, 2016
Last Update Posted: May 13, 2016
Last Verified: April 2016

Keywords provided by ApoPharma:
deferiprone
deferiprone delayed release formulation
pharmacokinetics

Additional relevant MeSH terms:
Pharmaceutical Solutions
Deferiprone
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action