- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02189941
Pilot Study of the Pharmacokinetic Profile of Deferiprone Sustained-Release Formulation in Healthy Volunteers
Pilot Study of the Pharmacokinetic Profile of a Single Dose of Deferiprone Sustained-Release Formulation in Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M9L 1P7
- Apotex Inc. BioClinical Development
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deferiprone sustained-release (fed)
A single 1000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.
|
Deferiprone sustained-release tablets
Other Names:
|
Experimental: Deferiprone sustained-release (fasting)
A single 1000 mg dose of deferiprone sustained-release under fasting conditions.
|
Deferiprone sustained-release tablets
Other Names:
|
Active Comparator: Deferiprone immediate-release (fasting)
A single 1000 mg dose of Deferiprone immediate-release under fasting conditions.
|
Deferiprone immediate-release tablets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCt for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time Frame: 24-hour interval
|
AUCt (Area Under the Curve to the last measured time) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite.
Blood samples were obtained prior to dosing and at 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.
|
24-hour interval
|
AUCinf for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time Frame: 24-hour interval
|
AUCinf (Area Under the Curve to infinity) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite.
Blood samples were obtained prior to dosing and at 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.
|
24-hour interval
|
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time Frame: 24-hour interval
|
Cmax (maximum concentration in the serum) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite.
Blood samples were obtained prior to dosing and at 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.
|
24-hour interval
|
Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time Frame: 24-hour interval
|
Tmax (the time to Cmax) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite.
Blood samples were obtained prior to dosing and at 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.
|
24-hour interval
|
Thalf for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time Frame: 24-hour interval
|
Thalf (the apparent terminal elimination half-life of the drug) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite.
Blood samples were obtained prior to dosing and at 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.
|
24-hour interval
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability of Deferiprone Sustained Release Tablets
Time Frame: From time of dose until 24 hours post dose
|
The number of participants who experienced adverse events between the time of dosing up to 24 hours post-dose, including any changes of clinical significance in vital signs, 12-lead ECG, and clinical laboratory tests
|
From time of dose until 24 hours post dose
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gurinder Rai, MD, Apotex Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LA43-0114
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Deferiprone sustained-release
-
ApoPharmaCompleted
-
Luye Pharma Group Ltd.RecruitingTardive Dyskinesia | Huntington DiseaseChina
-
Luye Pharma Group Ltd.CompletedTardive Dyskinesia | Huntington DiseaseChina
-
Luye Pharma Group Ltd.RecruitingGeneralized Anxiety DisorderChina
-
Jiangsu HengRui Medicine Co., Ltd.Active, not recruiting
-
Shanghai Mental Health CenterNot yet recruiting
-
Riphah International UniversityCompleted
-
Jiangsu HengRui Medicine Co., Ltd.UnknownChronic Systolic Heart FailureChina
-
Second Affiliated Hospital of Soochow UniversityActive, not recruitingSalivation in Parkinson's DiseaseChina
-
Royal Brompton & Harefield NHS Foundation TrustCORDA, The Heart Charity; Apotex Inc.; The Cooley's Anemia Foundation,; The UK...UnknownBeta-ThalassemiaItaly