Status:
COMPLETED
Pilot Study of the Pharmacokinetic Profile of Deferiprone Sustained-Release Formulation in Healthy Volunteers
Lead Sponsor:
ApoPharma
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 bi...
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 sustaine...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02189941
Start Date
May 1 2014
End Date
June 1 2014
Last Update
May 20 2016
Active Locations (1)
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1
Apotex Inc. BioClinical Development
Toronto, Ontario, Canada, M9L 1P7