Clinical trial NCT02442310: Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: deferiprone
deferiprone delayed release formulation
pharmacokinetics
Lead sponsor: ApoPharma
Sponsor class: INDUSTRY
Collaborators: name: Algorithme Pharma Inc
First posted: 2015-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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.

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. 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

Primary outcomes:
measure: Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
timeFrame: 24-hour interval
measure: Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
timeFrame: 24-hour interval
measure: AUC0-∞for Serum Deferiprone and Deferiprone 3-O-glucuronide
timeFrame: 24-hour interval
Secondary outcomes:
measure: Number of Subjects With Adverse Events (AEs)
timeFrame: Throughout the trial, from the time of the first dose until the last study visit (Day 30 or early termination)
Other outcomes:
Locations:
city: Mount-Royal
country: Canada
facility: Algorithme Pharma Inc.
state: Quebec
Study officials:
affiliation: ApoPharma Inc.
name: Fernando Tricta, MD
role: STUDY_CHAIR
References: