HealthyPhase 1NCT02442310
Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers
A Phase 1 study testing Deferiprone delayed release tablet formulation and Deferiprone oral solution in people with Healthy, run by ApoPharma at 1 site in Canada.
Trial summary
The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Deferiprone delayed release tablet formulation and Deferiprone oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Jul 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged ≥18 to <50 years
- 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
- 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
- Body mass index (BMI) greater than or equal to 18.5 kg/m^2 and below 30.0 kg/m^2
- Non- or ex smoker
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, an abnormal value must be without any clinical significance
- 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)
Who cannot join
- Pregnant or breastfeeding
- Absolute neutrophil count (ANC) < 1.8 x 109/L at screening (no repeat can be performed)
- 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
- 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
- Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- 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
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- 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)
- Any clinically significant illness in the previous 28 days before Day 1 of this study
- Serum ferritin value below the normal limit of the reference laboratory at screening
- Positive urine screening of alcohol and/or drugs of abuse
- Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Crossover Comparative Bioavailability Study of Deferiprone 600 mg Delayed Release Tablets Versus Deferiprone Oral Solution in Healthy Male and Female Volunteers Following a 1200 mg Dose
The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.
Read the detailed description
This is a single-center, open-label, randomized, 4-period crossover study of the pharmacokinetics of a new formulation of deferiprone, delayed 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
- Being tested
- Deferiprone delayed release tablet formulation, Deferiprone oral solution
- Keywords
- deferiprone, deferiprone delayed release formulation, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferiprone delayed release tablet formulationDrug
Also called Deferiprone
Deferiprone 600 mg delayed release tablet formulation
Deferiprone oral solutionDrug
Also called Ferriprox
Deferiprone 100 mg/mL oral solution
| Study group | Role | What they receive |
|---|---|---|
| Delayed release, fed conditions | Experimental | A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast Receives: Drug: Deferiprone delayed release tablet formulation |
| Delayed release, fasting conditions | Experimental | A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast Receives: Drug: Deferiprone delayed release tablet formulation |
| Delayed release half-tablets | Experimental | A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast Receives: Drug: Deferiprone delayed release tablet formulation |
| Oral solution, fasting conditions | Active comparator | A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast Receives: Drug: Deferiprone oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Measured: 24-hour interval
Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time to maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Measured: 24-hour interval
AUC0-∞for Serum Deferiprone and Deferiprone 3-O-glucuronide
Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Measured: 24-hour interval
Secondary outcomes (1)
Number of Subjects With Adverse Events (AEs)
Number of subjects with AEs, by frequency, severity, time to onset, duration, and relatedness to study product. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests.
Measured: Throughout the trial, from the time of the first dose until the last study visit (Day 30 or early termination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ApoPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Algorithme Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Fernando Tricta, MD, Study chair, ApoPharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442310
- Sponsor's protocol ID
- LA46-0114
- Status last verified
- Apr 2016
- First submitted
- 11 May 2015
- Last updated
- 13 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Crossover Comparative Bioavailability Study of Deferiprone 600 mg Delayed Release Tablets Versus Deferiprone Oral Solution in Healthy Male and Female Volunteers Following a 1200 mg Dose
- ClinicalTrials.gov ID
- NCT02442310
- Acronym / sponsor ID
- LA46-0114
- Conditions
- Healthy
- Keywords
- deferiprone, deferiprone delayed release formulation, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ApoPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Algorithme Pharma Inc
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Posted 13 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.
Detailed description
This is a single-center, open-label, randomized, 4-period crossover study of the pharmacokinetics of a new formulation of deferiprone, delayed 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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Delayed release, fed conditions | Experimental | Drug: Deferiprone delayed release tablet formulationA single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast |
| Delayed release, fasting conditions | Experimental | Drug: Deferiprone delayed release tablet formulationA single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast |
| Delayed release half-tablets | Experimental | Drug: Deferiprone delayed release tablet formulationA single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast |
| Oral solution, fasting conditions | Active comparator | Drug: Deferiprone oral solutionA single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female aged ≥18 to <50 years
- 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
- 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
- Body mass index (BMI) greater than or equal to 18.5 kg/m^2 and below 30.0 kg/m^2
- Non- or ex smoker
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding
- Absolute neutrophil count (ANC) < 1.8 x 109/L at screening (no repeat can be performed)
- 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
- 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
- Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deferiprone delayed release tablet formulationAlso: DeferiproneDeferiprone 600 mg delayed release tablet formulation | Drug | Delayed release half-tablets, Delayed release, fasting conditions, Delayed release, fed conditions |
| Deferiprone oral solutionAlso: FerriproxDeferiprone 100 mg/mL oral solution | Drug | Oral solution, fasting conditions |
Primary outcome
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time frame: 24-hour interval
Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time frame: 24-hour interval
Time to maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
AUC0-∞for Serum Deferiprone and Deferiprone 3-O-glucuronide
Time frame: 24-hour interval
Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
1 secondary outcome
Number of Subjects With Adverse Events (AEs)
Time frame: Throughout the trial, from the time of the first dose until the last study visit (Day 30 or early termination)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Tricta, MD study chair
ApoPharma Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deferiprone delayed release tablet formulation and Deferiprone oral solution in people with Healthy, run by ApoPharma at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide (time frame: 24-hour interval). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.