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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189941
• Other study ID #: LA43-0114
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2014
• Last updated: July 11, 2014
• Start date: May 2014
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: ApoPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Main 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Deferiprone sustained-release

• Deferiprone immediate-release

Locations

Country	Name	City	State
Canada	Apotex Inc. BioClinical Development	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
ApoPharma

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt from serum deferiprone and deferiprone 3-O-glucuronide concentration-time profiles.		pre-dose and 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose	No
Primary	AUCinf from serum deferiprone and deferiprone 3-O-glucuronide concentration-time profiles.		pre-dose and 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose	No
Primary	Cmax from serum deferiprone and deferiprone 3-O-glucuronide concentration-time profiles.		pre-dose and 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose	No
Primary	Tmax from serum deferiprone and deferiprone 3-O-glucuronide concentration-time profiles.		pre-dose and 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose	No
Primary	Thalf from serum deferiprone and deferiprone 3-O-glucuronide concentration-time profiles.		pre-dose and 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose	No
Secondary	To evaluate the safety and tolerability of deferiprone sustained release tablets	Safety and tolerability will be assessed based on changes in: vital signs, 12-lead ECG, clinical laboratory tests, and frequency of adverse events (AEs)	Prior to dosing until 24 hrs post-dose	Yes