Pilot Study of the Pharmacokinetic Profile of Deferiprone Sustained-Release Formulation in Healthy Volunteers

NCT ID: NCT02189941

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-06-30

Brief Summary

The purpose of this study was to evaluate the pharmacokinetic and safety profile of the sustained-release formulation of deferiprone under both fasting and fed conditions, and evaluate the relative bioavailability of this sustained-release formulation when compared to immediate-release formulation of deferiprone under fasting conditions.

Detailed Description

This was an open-label, single-dose, randomized, three-way crossover study under fed and fasting conditions designed to determine the pharmacokinetics, safety, and tolerability of deferiprone sustained-release tablets in healthy volunteers. Subjects were randomized to receive the following 3 treatments in different orders, with a washout period of 7 days between treatments:

• 2000 mg of deferiprone sustained-release tablets under fed conditions
• 2000 mg of deferiprone sustained-release tablets under fasted conditions
• 2000 mg of Ferriprox immediate-release tablets under fasted conditions

In each period, blood samples for pharmacokinetics (PK) assessment were collected prior to dosing and at specified time points up to 24 hours post-dose. Safety assessments were conducted throughout the study.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Deferiprone sustained-release (fed)

A single 1000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.

Group Type: EXPERIMENTAL

Deferiprone sustained-release

Intervention Type: DRUG

Deferiprone sustained-release tablets

Deferiprone sustained-release (fasting)

A single 1000 mg dose of deferiprone sustained-release under fasting conditions.

Group Type: EXPERIMENTAL

Deferiprone sustained-release

Intervention Type: DRUG

Deferiprone sustained-release tablets

Deferiprone immediate-release (fasting)

A single 1000 mg dose of Deferiprone immediate-release under fasting conditions.

Group Type: ACTIVE_COMPARATOR

Deferiprone immediate-release

Intervention Type: DRUG

Deferiprone immediate-release tablets

Interventions

Deferiprone sustained-release

Deferiprone sustained-release tablets

Intervention Type: DRUG

Deferiprone immediate-release

Deferiprone immediate-release tablets

Intervention Type: DRUG

Other Intervention Names

Deferiprone; Ferriprox

Eligibility Criteria

Inclusion Criteria

• Meeting the age, body mass index (BMI) and weight requirements.
• Signing the Informed Consent Form.
• Acceptable alcohol and/or drug screen at check-in of each period.
• Acceptable health, blood pressure, pulse rate and temperature at check-in.
• Being a non-smoker.
• Female subjects of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose of the study and throughout the study, and for 30 days after completion of the study, or be using an acceptable method of birth control.

Exclusion Criteria

• A history of presence of significant asthma, chronic bronchitis, seizure, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological conditions, psychiatric conditions, hepatic, renal, hematopoietic or gastrointestinal diseases or ongoing infectious diseases, or any other significant abnormality as evidenced by a medical history and physical examination.
• Blood chemistry, hematology, international normalized ratio, partial thromboplastin time and urinalysis values outside clinically acceptable limits.
• A positive screen for Hepatitis B surface antigens, Hepatitis C antibodies or HIV.
• Significant abnormality found on ECG.
• Known sensitivity to deferiprone or any components of the Ferriprox tablets.
• Requiring other medication at the time of the study. Oral, injectable or topical contraceptives, and contraceptive implants are permitted as they are acceptable methods of contraception.
• Acetaminophen use within 2 weeks prior to dosing and for the duration of the study.
• History of drug or alcohol abuse within the last 6 months.
• Any known enzyme inducing or inhibiting drug taken within 30 days before the study.
• History of long QT syndrome, cardiac arrhythmias.
• Infection within two weeks prior to dosing.
• Participation in an investigational drug study within 30 days prior to first dosing in this study.
• Blood donation of 50 mL to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56 days prior to drug administration.
• Positive test for pregnancy at medical screening or prior to dosing in either period.
• Female subjects who are breast-feeding.
• Absolute neutrophil count (ANC) <= 1.0 x 10E9 cells/L prior to dosing for each period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ApoPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gurinder Rai, MD

Role: PRINCIPAL_INVESTIGATOR

Apotex Inc.

Locations

Apotex Inc. BioClinical Development

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

LA43-0114

Identifier Type: -

Identifier Source: org_study_id