HealthyPhase 1NCT02189941

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

A Phase 1 study testing Deferiprone sustained-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 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 bioavailability of this sustained-release formulation when compared to immediate-release formulation of deferiprone under… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Deferiprone sustained-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: 11 participants
Where: 1 siteCanada
Study dates: May 2014to Jun 2014
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

None listed.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Apotex Inc. BioClinical Development
Toronto, Ontario, M9L 1P7

Other trials in Canada

About this study

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

Read the 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.

Conditions: Healthy
Being tested: Deferiprone sustained-release, Deferiprone immediate-release
Keywords: Deferiprone, Deferiprone sustained-release tablets, Pharmacokinetics

What participants receive

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

Deferiprone sustained-releaseDrug
Also called Deferiprone
Deferiprone sustained-release tablets
Deferiprone immediate-releaseDrug
Also called Ferriprox
Deferiprone immediate-release tablets

Study groups in NCT02189941
Study group	Role	What they receive
Deferiprone sustained-release (fed)	Experimental	A single 1000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast. Receives: Drug: Deferiprone sustained-release
Deferiprone sustained-release (fasting)	Experimental	A single 1000 mg dose of deferiprone sustained-release under fasting conditions. Receives: Drug: Deferiprone sustained-release
Deferiprone immediate-release (fasting)	Active comparator	A single 1000 mg dose of Deferiprone immediate-release under fasting conditions. Receives: Drug: Deferiprone immediate-release

What is being measured

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

AUCt for Serum Deferiprone and Deferiprone 3-O-glucuronide
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.
Measured: 24-hour interval
AUCinf for Serum Deferiprone and Deferiprone 3-O-glucuronide
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.
Measured: 24-hour interval
Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
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.
Measured: 24-hour interval
Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide
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.
Measured: 24-hour interval
Thalf for Serum Deferiprone and Deferiprone 3-O-glucuronide
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.
Measured: 24-hour interval

Secondary outcomes (1)

Safety and Tolerability of Deferiprone Sustained Release Tablets
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
Measured: From time of dose until 24 hours post dose

Timeline

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

May 2014Jun 2014

First posted15 Jul 2014 (estimated)
Study startMay 2014
Primary completionJun 2014
Study completionJun 2014

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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02189941
Sponsor's protocol ID: LA43-0114
Status last verified: Apr 2016
First submitted: 11 Jul 2014
Last updated: 20 May 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 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of the Pharmacokinetic Profile of a Single Dose of Deferiprone Sustained-Release Formulation in Healthy Volunteers
ClinicalTrials.gov ID: NCT02189941
Acronym / sponsor ID: LA43-0114
Conditions: Healthy
Keywords: Deferiprone, Deferiprone sustained-release tablets, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: ApoPharmaIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 15 Jul 2014 (estimated)
Results: Posted 20 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Deferiprone sustained-release (fed)	Experimental	Drug: Deferiprone sustained-releaseA single 1000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.
Deferiprone sustained-release (fasting)	Experimental	Drug: Deferiprone sustained-releaseA single 1000 mg dose of deferiprone sustained-release under fasting conditions.
Deferiprone immediate-release (fasting)	Active comparator	Drug: Deferiprone immediate-releaseA single 1000 mg dose of Deferiprone immediate-release under fasting conditions.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (16 listed)

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.

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 sustained-releaseAlso: DeferiproneDeferiprone sustained-release tablets	Drug	Deferiprone sustained-release (fasting), Deferiprone sustained-release (fed)
Deferiprone immediate-releaseAlso: FerriproxDeferiprone immediate-release tablets	Drug	Deferiprone immediate-release (fasting)

Primary outcome

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.
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.
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.
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.
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.

1 secondary outcome

Safety and Tolerability of Deferiprone Sustained Release Tablets
Time frame: From time of dose until 24 hours post dose

Results and safety

Results posted to the registry on 20 May 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
DFP-SR Fed, Then DFP-SR Fasting, Then Ferriprox Fasting	4	4
DFP-SR Fasting, Then Ferriprox Fasting, Then DFP-SR Fed	4	4
Ferriprox Fasting, Then DFP-SR Fed, Then DFP-SR Fasting	3	2

Primary outcome: AUCt for Serum Deferiprone and Deferiprone 3-O-glucuronide

Time frame: 24-hour interval. Mean (Standard Deviation). Unit: mcg*h/mL

Measure	Deferiprone Sustained-release (Fed) n = 10	Deferiprone Sustained-release (Fasting) n = 10	Deferiprone Immediate-release (Fasting) n = 11
Deferiprone	63.5 (10.0)	52.3 (14.8)	71.1 (10.9)
Deferiprone 3-O-glucuronide	171.9 (33.4)	147.2 (41.5)	192.7 (32.8)

Population analysed: All subjects who contributed evaluable pharmacokinetics data

Primary outcome: AUCinf for Serum Deferiprone and Deferiprone 3-O-glucuronide

Time frame: 24-hour interval. Mean (Standard Deviation). Unit: mcg*h/mL

Measure	Deferiprone Sustained-release (Fed) n = 10	Deferiprone Sustained-release (Fasting) n = 10	Deferiprone Immediate-release (Fasting) n = 11
Deferiprone	66.2 (11.1)	57.2 (16.1)	71.6 (11.0)
Deferiprone 3-O-glucuronide	181.3 (39.9)	169.2 (62.3)	193.4 (32.5)

Population analysed: All subjects who contributed evaluable pharmacokinetics data

Primary outcome: Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide

Time frame: 24-hour interval. Mean (Standard Deviation). Unit: mcg/mL

Measure	Deferiprone Sustained-release (Fed) n = 10	Deferiprone Sustained-release (Fasting) n = 10	Deferiprone Immediate-release (Fasting) n = 11
Deferiprone	8.7 (1.8)	5.8 (1.6)	21.9 (6.9)
Deferiprone 3-O-glucuronide	18.5 (4.2)	14.3 (2.9)	33.2 (5.0)

Population analysed: All subjects who contributed evaluable pharmacokinetics data

Primary outcome: Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide

Time frame: 24-hour interval. Mean (Standard Deviation). Unit: h

Measure	Deferiprone Sustained-release (Fed) n = 10	Deferiprone Sustained-release (Fasting) n = 10	Deferiprone Immediate-release (Fasting) n = 10
Deferiprone	4.4 (0.9)	3.3 (1.4)	1.3 (1.1)
Deferiprone 3-O-glucuronide	6.0 (1.5)	4.5 (1.5)	3.0 (0.9)

Population analysed: All subjects who contributed evaluable pharmacokinetics data

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Deferiprone Sustained-release (Fed)	0 of 10 (0%)	5 of 10 (50%)	Not reported
Deferiprone Sustained-release (Fasting)	0 of 10 (0%)	5 of 10 (50%)	Not reported
Deferiprone Immediate-release (Fasting)	0 of 11 (0%)	6 of 11 (54.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 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.

Gurinder Rai, MD principal investigator

Apotex 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 sustained-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 0 inclusion and 16 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 20 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 20 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?

AUCt for Serum Deferiprone and Deferiprone 3-O-glucuronide (time frame: 24-hour interval). The study lists 5 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 NCT02189941.

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 20 May 2016.