Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers

NCT ID: NCT02465489

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-08-31

Brief 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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

ER, fasting conditions

A single 1000 mg dose of deferiprone extended release tablet formulation administered under fasting conditions

Group Type: EXPERIMENTAL

Deferiprone extended release

Intervention Type: DRUG

Deferiprone 1000 mg extended release tablet formulation

ER, fed conditions

A single 1000 mg dose of deferiprone extended release tablet formulation administered under fed conditions

Group Type: EXPERIMENTAL

Deferiprone extended release

Intervention Type: DRUG

Deferiprone 1000 mg extended release tablet formulation

ER half-tablets, fed conditions

A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered under fed conditions

Group Type: EXPERIMENTAL

Deferiprone extended release

Intervention Type: DRUG

Deferiprone 1000 mg extended release tablet formulation

IR, fasting conditions

A single 1000 mg dose of deferiprone immediate release tablet formulation administered under fasting conditions

Group Type: ACTIVE_COMPARATOR

Deferiprone immediate release

Intervention Type: DRUG

Ferriprox (deferiprone) 500 mg immediate release tablet formulation

IR, fed conditions

A single 1000 mg dose of deferiprone immediate release tablet formulation administered under fed conditions

Group Type: ACTIVE_COMPARATOR

Deferiprone immediate release

Intervention Type: DRUG

Ferriprox (deferiprone) 500 mg immediate release tablet formulation

Interventions

Deferiprone extended release

Deferiprone 1000 mg extended release tablet formulation

Intervention Type: DRUG

Deferiprone immediate release

Ferriprox (deferiprone) 500 mg immediate release tablet formulation

Intervention Type: DRUG

Other Intervention Names

Deferiprone extended release tablet formulation; Ferriprox immediate release tablet formulation

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ApoPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Sicard, MD

Role: PRINCIPAL_INVESTIGATOR

Algorithme Pharma Inc

Locations

Algorithme Pharma Inc.

Mount Royal, Quebec, Canada

Countries

Canada

Other Identifiers

LA51-0115

Identifier Type: -

Identifier Source: org_study_id