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Pharmacokinetics of Granule and Tablet Formulations of Deferitazole (Disodium Salt) and a Capsule Formulation of Deferitazole (Magnesium Hydroxide Salt)

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ClinicalTrials.gov Identifier: NCT02065401
Recruitment Status : Withdrawn (This study was withdrawn until the evaluation of the nonclinical rat findings is complete.)
First Posted : February 19, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Deferitazole (disodium salt, granule) Drug: Deferitazole (disodium salt, tablet) Drug: Deferitazole (magnesium hydroxide salt) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : February 2014
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Experimental: Deferitazole (disodium salt, granule) Drug: Deferitazole (disodium salt, granule)
Single oral dose of 1500 mg administered on Day 1
Other Name: SPD602, SSP-004184, SSP-004184SS

Experimental: Deferitazole (disodium salt, tablet) Drug: Deferitazole (disodium salt, tablet)
Single oral dose of 1500 mg administered on Day 1
Other Name: SPD602, SSP-004184, SSP-004184SS

Experimental: Deferitazole (magnesium hydroxide salt) Drug: Deferitazole (magnesium hydroxide salt)
Single oral dose of 2400 mg administered on Day 1
Other Name: SPD602, SSP-004184AQ, SSP-004184




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Taste of Deferitazole [ Time Frame: Immediately after dose and 5 minutes post-dose ]
  2. Bioequivalence of Deferitazole Disodium Salt Granule Formulation With Tablet Formulation [ Time Frame: Up to 120 hours post-dose ]
    Compare the pharmacokinetic profile of granule formulation with pharmacokinetic profile of tablet formulation



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-65 years inclusive at the time of consent.
  2. Must be considered "healthy".
  3. Serum ferritin, hemoglobin and erythrocyte indices (packed cell volume, mean corpuscular volume and mean corpuscular hemoglobin concentration) within normal range.
  4. 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 )
    • Non-pregnant, non-lactating female
    • Females must be at least 90 days post partum or nulliparous.
  5. Body weight equal to or greater than 60kg.
  6. Ability to swallow a dose of the investigational product.

Exclusion Criteria:

  1. Subject has a clinically significant history or a disorder detected during the medical interview/physical examination.
  2. Acute illness.
  3. 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.
    • 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.
  4. Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment.
  5. History of alcohol or other substance abuse within the year.
  6. A positive screen for alcohol or drugs of abuse.
  7. Confirmed systolic blood pressure >139mmHg or <89mmHg, and diastolic blood pressure >89mmHg or<49mmHg.
  8. Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches.
  9. Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day.
  10. A positive human immunodeficiency virus antibody screen, hepatitis B surface antigen, or hepatitis C virus antibody.
  11. Current use of any other medication (including over-the-counter, herbal, or homeopathic preparations)
  12. Current use of iron supplements and/or multivitamins.
  13. Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products.
  14. Donation of blood or blood products (e.g., plasma or platelets) within 60 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065401


Locations
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United States, Florida
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
Sponsors and Collaborators
Shire

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02065401     History of Changes
Other Study ID Numbers: SPD602-112
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
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Magnesium Hydroxide
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents