Clinical trial NCT02065401: Pharmacokinetics of Granule and Tablet Formulations of Deferitazole (Disodium Salt) and a Capsule Formulation of Deferitazole (Magnesium Hydroxide Salt)
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-02-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve (AUC) of Deferitazole
timeFrame: Up to 120 hours post-dose
measure: Maximum Plasma Concentration (Cmax) of Deferitazole
timeFrame: Up to 120 hours post-dose
Secondary outcomes:
measure: Taste of Deferitazole
timeFrame: Immediately after dose and 5 minutes post-dose
measure: Bioequivalence of Deferitazole Disodium Salt Granule Formulation With Tablet Formulation
timeFrame: Up to 120 hours post-dose
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: