HealthyPhase 1NCT02465489

Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers

A Phase 1 study testing Deferiprone extended release and Deferiprone immediate release in people with Healthy, run by ApoPharma at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone extended 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 extended release and Deferiprone immediate release
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: Jun 2015to Aug 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
Body weight of at least 60 kg
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
Suicidal tendency, history of seizures, history of head trauma with coma or craniotomy/trepanation, state of confusion, or clinically relevant psychiatric diseases

Show all 17Show fewer

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
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
Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 28 days before Day 1 of this study
Any history of tuberculosis and/or prophylaxis for tuberculosis
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 on HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests
Positive result on a serum pregnancy test
Receipt of an investigational product in another clinical trial in the previous 28 days before Day 1 of this study
Donation of 50 mL or more of blood in the previous 28 days before Day 1 of this study or donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before Day 1 of this study

Trial locations and contacts

1 site in 1 country.

Canada1 site

Algorithme Pharma Inc.
Mount Royal, Quebec, H3P 3P1

Other trials in Canada

About this study

Official title: Single-dose Pharmacokinetic Study of Deferiprone Extended Release Tablets Versus Ferriprox Immediate Release Tablets Under Fasting and Fed Conditions in Healthy Volunteers

The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone extended release tablets) under fed and fasting conditions.

Read the detailed description

This is a single-center, open-label, randomized, 5-period, 5-sequence study of the pharmacokinetics of a new formulation of deferiprone, extended 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 extended release, Deferiprone immediate release
Keywords: deferiprone, deferiprone extended release formulation, pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Deferiprone extended releaseDrug
Also called Deferiprone extended release tablet formulation
Deferiprone 1000 mg extended release tablet formulation
Deferiprone immediate releaseDrug
Also called Ferriprox immediate release tablet formulation
Ferriprox (deferiprone) 500 mg immediate release tablet formulation

Study groups in NCT02465489
Study group	Role	What they receive
ER, fasting conditions	Experimental	A single 1000 mg dose of deferiprone extended release tablet formulation administered under fasting conditions Receives: Drug: Deferiprone extended release
ER, fed conditions	Experimental	A single 1000 mg dose of deferiprone extended release tablet formulation administered under fed conditions Receives: Drug: Deferiprone extended release
ER half-tablets, fed conditions	Experimental	A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered under fed conditions Receives: Drug: Deferiprone extended release
IR, fasting conditions	Active comparator	A single 1000 mg dose of deferiprone immediate release tablet formulation administered under fasting conditions Receives: Drug: Deferiprone immediate release
IR, fed conditions	Active comparator	A single 1000 mg dose of deferiprone immediate release tablet formulation administered under fed conditions Receives: Drug: Deferiprone immediate release

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax for Serum Deferiprone
Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Measured: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.
Tmax for Serum Deferiprone
Time of maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Measured: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.
AUC0-∞for Serum Deferiprone
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: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.

Secondary outcomes (1)

Number of Subjects With Adverse Events (AEs)
Number of subjects with AEs. 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 36 or early termination)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Aug 2015

First posted8 Jun 2015 (estimated)
Study startJun 2015
Primary completionAug 2015
Study completionAug 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02465489
Sponsor's protocol ID: LA51-0115
Status last verified: Jun 2015
First submitted: 4 Jun 2015
Last updated: 26 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-dose Pharmacokinetic Study of Deferiprone Extended Release Tablets Versus Ferriprox Immediate Release Tablets Under Fasting and Fed Conditions in Healthy Volunteers
ClinicalTrials.gov ID: NCT02465489
Acronym / sponsor ID: LA51-0115
Conditions: Healthy
Keywords: deferiprone, deferiprone extended release formulation, pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: ApoPharmaIndustry (pharma, biotech, devices)
Study start: Jun 2015
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 8 Jun 2015 (estimated)
Results: Posted 26 Jan 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 extended release tablets) under fed and fasting conditions.

Detailed description

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
ER, fasting conditions	Experimental	Drug: Deferiprone extended releaseA single 1000 mg dose of deferiprone extended release tablet formulation administered under fasting conditions
ER, fed conditions	Experimental	Drug: Deferiprone extended releaseA single 1000 mg dose of deferiprone extended release tablet formulation administered under fed conditions
ER half-tablets, fed conditions	Experimental	Drug: Deferiprone extended releaseA single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered under fed conditions
IR, fasting conditions	Active comparator	Drug: Deferiprone immediate releaseA single 1000 mg dose of deferiprone immediate release tablet formulation administered under fasting conditions
IR, fed conditions	Active comparator	Drug: Deferiprone immediate releaseA single 1000 mg dose of deferiprone immediate release tablet formulation administered under fed conditions

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 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
Body weight of at least 60 kg

Key exclusion criteria (17 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 extended releaseAlso: Deferiprone extended release tablet formulationDeferiprone 1000 mg extended release tablet formulation	Drug	ER half-tablets, fed conditions, ER, fasting conditions, ER, fed conditions
Deferiprone immediate releaseAlso: Ferriprox immediate release tablet formulationFerriprox (deferiprone) 500 mg immediate release tablet formulation	Drug	IR, fasting conditions, IR, fed conditions

Primary outcome

Cmax for Serum Deferiprone
Time frame: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.
Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
Tmax for Serum Deferiprone
Time frame: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.
Time of maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose
AUC0-∞for Serum Deferiprone
Time frame: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.
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 36 or early termination)

Results and safety

Results posted to the registry on 26 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Volunteers	20	15

Primary outcome: Cmax for Serum Deferiprone

Time frame: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.. Mean (Standard Deviation). Unit: μg/mL

Measure	Extended Release, Fasting Conditions n = 16	Extended Release, Fed Conditions n = 16	Extended Release Half-tablets, Fed Conditions n = 14	Immediate Release, Fasting Conditions n = 16	Immediate Release, Fed Conditions n = 15
Value	3.89 (1.47)	2.76 (1.45)	3.02 (1.03)	13.89 (3.84)	9.77 (3.60)

Population analysed: The pharmacokinetic population included subjects who provided evaluable data for at least two study periods.

Primary outcome: Tmax for Serum Deferiprone

Measure	Extended Release, Fasting Conditions n = 16	Extended Release, Fed Conditions n = 16	Extended Release Half-tablets, Fed Conditions n = 14	Immediate Release, Fasting Conditions n = 16	Immediate Release, Fed Conditions n = 15
Value	3.63 (1.10)	15.66 (9.33)	8.29 (7.25)	0.94 (0.63)	1.91 (0.95)

Population analysed: The pharmacokinetic population included subjects who provided evaluable data for at least two study periods

Primary outcome: AUC0-∞for Serum Deferiprone

Measure	Extended Release, Fasting Conditions n = 15	Extended Release, Fed Conditions n = 2	Extended Release Half-tablets, Fed Conditions n = 5	Immediate Release, Fasting Conditions n = 16	Immediate Release, Fed Conditions n = 15
Value	31.42 (6.68)	40.52 (0.77)	31.72 (8.21)	34.81 (6.81)	33.02 (7.19)

Population analysed: The pharmacokinetic population included subjects who provided evaluable data for at least two study periods

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from the administration of the first dose in period 1 until the end-of-study visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Extended Release, Fasting Conditions	0 of 18 (0%)	5 of 18 (27.8%)	Not reported
Extended Release, Fed Conditions	0 of 16 (0%)	2 of 16 (12.5%)	Not reported
Extended Release Half-tablets, Fed Conditions	0 of 16 (0%)	3 of 16 (18.8%)	Not reported
Immediate Release, Fasting Conditions	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
Immediate Release, Fed Conditions	0 of 16 (0%)	3 of 16 (18.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 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.

Eric Sicard, MD principal investigator

Algorithme Pharma 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 extended release and Deferiprone immediate release 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 8 inclusion and 17 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 26 Feb 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 26 Jan 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 (time frame: Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.). 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?

On the ClinicalTrials.gov record for NCT02465489.

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 26 Feb 2016.