HealthyPhase 1NCT02065401
Pharmacokinetics of Granule and Tablet Formulations of Deferitazole (Disodium Salt) and a Capsule Formulation of Deferitazole (Magnesium Hydroxide Salt)
A Phase 1 study testing Deferitazole (disodium salt, granule), Deferitazole (disodium salt, tablet) and Deferitazole (magnesium hydroxide salt) in people with Healthy, run by Shire at 1 site in United States.
Trial summary
The purpose of this study is to compare the pharmacokinetic profiles of deferitazole after administration of granule and tablet formulations of a deferitazole disodium salt to a capsule formulation of deferitazole magnesium hydroxide salt (reference formulation) in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Deferitazole (disodium salt, granule), Deferitazole (disodium salt, tablet) and Deferitazole (magnesium hydroxide salt)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2014to 19 Mar 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years inclusive at the time of consent.
- Must be considered "healthy".
- Serum ferritin, hemoglobin and erythrocyte indices (packed cell volume, mean corpuscular volume and mean corpuscular hemoglobin concentration) within normal range.
- Willingness to comply with any applicable contraceptive requirements of the protocol and is:
- Male, or
- Female of non-childbearing potential (defined as a female who is post-menopausal )
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- Non-pregnant, non-lactating female
- Females must be at least 90 days post partum or nulliparous.
- Body weight equal to or greater than 60kg.
- Ability to swallow a dose of the investigational product.
Who cannot join
- Subject has a clinically significant history or a disorder detected during the medical interview/physical examination.
- Acute illness.
- Oral condition:
- Has history of oral surgery (including extractions) within 4 weeks, operative dental work within 7 days, or a presence of any clinically significant oral pathology (as determined by the investigator) including lesions, sores or inflammation which would interfere with assessments.
- Has fixed retainers, orthodontic appliances, or either maxillary and/or mandibular dentures or other appliances which may interfere with swilling or tasting the formulations.
- Has current or recurrent disease that could affect the mouth and interfere with the taste assessment.
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- Has severe gingivitis, periodontitis or rampant caries.
- Has the presence of oral or peri-oral ulceration including herpetic lesions
- Has elective dentistry scheduled during the study duration.
- Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment.
- History of alcohol or other substance abuse within the year.
- A positive screen for alcohol or drugs of abuse.
- Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or<49mmHg.
- Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches.
- Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
- A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody.
- Current use of any other medication (including over-the-counter, herbal, or homeopathic preparations)
- Current use of iron supplements and/or multivitamins.
- Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products.
- Donation of blood or blood products (e.g., plasma or platelets) within 60 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami
Miami, Florida, 33014
About this study
Official title: A Phase 1, Open-label, Randomized, 3-Period, Relative Bioavailability Study Comparing the Pharmacokinetics of Granule and Tablet Formulations of Deferitazole (Disodium Salt) and a Capsule Formulation of Deferitazole (Magnesium Hydroxide Salt), Each Administered as a Single Oral Dose
The purpose of this study is to compare the pharmacokinetic profiles of deferitazole after administration of granule and tablet formulations of a deferitazole disodium salt to a capsule formulation of deferitazole magnesium hydroxide salt (reference formulation) in healthy adult subjects.
- Conditions
- Healthy
- Being tested
- Deferitazole (disodium salt, granule), Deferitazole (disodium salt, tablet), Deferitazole (magnesium hydroxide salt)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deferitazole (disodium salt, granule)Drug
Also called SPD602, SSP-004184, SSP-004184SS
Single oral dose of 1500 mg administered on Day 1
Deferitazole (disodium salt, tablet)Drug
Also called SPD602, SSP-004184, SSP-004184SS
Single oral dose of 1500 mg administered on Day 1
Deferitazole (magnesium hydroxide salt)Drug
Also called SPD602, SSP-004184AQ, SSP-004184
Single oral dose of 2400 mg administered on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Deferitazole (disodium salt, granule) | Experimental | Not described Receives: Drug: Deferitazole (disodium salt, granule) |
| Deferitazole (disodium salt, tablet) | Experimental | Not described Receives: Drug: Deferitazole (disodium salt, tablet) |
| Deferitazole (magnesium hydroxide salt) | Experimental | Not described Receives: Drug: Deferitazole (magnesium hydroxide salt) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve (AUC) of Deferitazole
AUC of disodium salt granule, disodium salt tablet, and magnesium hydroxide salt
Measured: Up to 120 hours post-dose
Maximum Plasma Concentration (Cmax) of Deferitazole
Cmax of disodium salt granule, disodium salt tablet, and magnesium hydroxide salt
Measured: Up to 120 hours post-dose
Secondary outcomes (2)
Taste of Deferitazole
Measured: Immediately after dose and 5 minutes post-dose
Bioequivalence of Deferitazole Disodium Salt Granule Formulation With Tablet Formulation
Compare the pharmacokinetic profile of granule formulation with pharmacokinetic profile of tablet formulation
Measured: Up to 120 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study start28 Feb 2014 (estimated)
- Primary completion19 Mar 2014 (estimated)
- Study completion19 Mar 2014 (estimated)
Why it stopped: This study was withdrawn until the evaluation of the nonclinical rat findings is complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065401
- Sponsor's protocol ID
- SPD602-112
- Status last verified
- May 2021
- First submitted
- 10 Feb 2014
- Last updated
- 2 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, 3-Period, Relative Bioavailability Study Comparing the Pharmacokinetics of Granule and Tablet Formulations of Deferitazole (Disodium Salt) and a Capsule Formulation of Deferitazole (Magnesium Hydroxide Salt), Each Administered as a Single Oral Dose
- ClinicalTrials.gov ID
- NCT02065401
- Acronym / sponsor ID
- SPD602-112
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn until the evaluation of the nonclinical rat findings is complete.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2014 (estimated)
- Primary completion
- 19 Mar 2014 (estimated)
- Study completion
- 19 Mar 2014 (estimated)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
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 compare the pharmacokinetic profiles of deferitazole after administration of granule and tablet formulations of a deferitazole disodium salt to a capsule formulation of deferitazole magnesium hydroxide salt (reference formulation) in healthy adult subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deferitazole (disodium salt, granule) | Experimental | Drug: Deferitazole (disodium salt, granule) |
| Deferitazole (disodium salt, tablet) | Experimental | Drug: Deferitazole (disodium salt, tablet) |
| Deferitazole (magnesium hydroxide salt) | Experimental | Drug: Deferitazole (magnesium hydroxide salt) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-65 years inclusive at the time of consent.
- Must be considered "healthy".
- Serum ferritin, hemoglobin and erythrocyte indices (packed cell volume, mean corpuscular volume and mean corpuscular hemoglobin concentration) within normal range.
- Willingness to comply with any applicable contraceptive requirements of the protocol and is:
- Body weight equal to or greater than 60kg.
Key exclusion criteria (20 listed)
- Subject has a clinically significant history or a disorder detected during the medical interview/physical examination.
- Acute illness.
- Oral condition:
- Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment.
- History of alcohol or other substance abuse within the year.
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 |
|---|---|---|
| Deferitazole (disodium salt, granule)Also: SPD602, SSP-004184, SSP-004184SSSingle oral dose of 1500 mg administered on Day 1 | Drug | Deferitazole (disodium salt, granule) |
| Deferitazole (disodium salt, tablet)Also: SPD602, SSP-004184, SSP-004184SSSingle oral dose of 1500 mg administered on Day 1 | Drug | Deferitazole (disodium salt, tablet) |
| Deferitazole (magnesium hydroxide salt)Also: SPD602, SSP-004184AQ, SSP-004184Single oral dose of 2400 mg administered on Day 1 | Drug | Deferitazole (magnesium hydroxide salt) |
Primary outcome
Area Under the Plasma Concentration-time Curve (AUC) of Deferitazole
Time frame: Up to 120 hours post-dose
AUC of disodium salt granule, disodium salt tablet, and magnesium hydroxide salt
Maximum Plasma Concentration (Cmax) of Deferitazole
Time frame: Up to 120 hours post-dose
Cmax of disodium salt granule, disodium salt tablet, and magnesium hydroxide salt
2 secondary outcomes
Taste of Deferitazole
Time frame: Immediately after dose and 5 minutes post-dose
Bioequivalence of Deferitazole Disodium Salt Granule Formulation With Tablet Formulation
Time frame: Up to 120 hours post-dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
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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.
Study Director study director
Takeda
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 Deferitazole (disodium salt, granule), Deferitazole (disodium salt, tablet) and Deferitazole (magnesium hydroxide salt) in people with Healthy, run by Shire at 1 site in United States.
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 10 inclusion and 20 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: withdrawn, as of the sponsor's last update on 2 Jun 2021. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Area Under the Plasma Concentration-time Curve (AUC) of Deferitazole (time frame: Up to 120 hours post-dose). The study lists 2 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 2 Jun 2021.